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Color additives

FDA OKs using pearly pigments to color tablets

By Validation Times Staff

FDA issued a final rule July 20 allowing manufacturers to start using color additives in pharmaceuticals that are similar to those that give cosmetics a pearly sheen.

The pearlescent pigments can be used in any drugs that are swallowed, including pills, tablets and liquids, FDA noted.

The pigments can produce sparkly metallic, satiny and shimmery finishes, as well as different hues of red and gold, depending partly on the color of the underlying drug.

FDAís publication of a final rule approving their use came eight years after EMD Chemicals of Gibbstown, NJ, first petitioned the agency. The chemical and pigment maker is part of Merck KgaA in Germany.

EMD Chemicals hopes the pharmaceutical companies it supplies will seize on the technology to give their drugs a look that is unique and hard to copy, said Dan Giambattisto, sales and marketing director for Candurin Pigments at EMD Chemicals.

The pigments are made by coating the mineral mica with either titanium dioxide or iron oxide ó or both. The FDA approved using the two separate combinations to color contact lenses in 2002.

Similar pigments also are used in makeup, including lipstick, eye shadow and nail polish, as well as in inks and automotive paint.

Titanium dioxide already can be used in drugs. The new rule allows mica to be used to color drugs meant to be swallowed and increases the amount of synthetic iron dioxide allowed in those medicines. The pigments cannot make up more than 3% of the weight of a drug, the FDA said.

In the rule, first published on July 22, 2005, the agency said it ìconcludes that there is no toxic potential when ingested at levels estimated by the agency.î FDA delayed making the rule final until July 20, after it answered the objections of critics.

Gatewood Organization LLC, a regulatory consulting group in Hazlet, NJ, had questioned whether the pigments would put some drugs off limits to patients who must watch their intake of iron and whether they would affect the shelf life of drugs.

FDA denied the groupís objections, saying it had provided no ìfactual informationî to back up its claims. ìAfter reviewing the objections, the agency has concluded that the objections do not raise issues of material fact that justify a hearing or otherwise provide a basis for revoking the amendment to the regulations,î FDA wrote in the ìFederal Registerî announcement (Volume 71, Number 139, Page 41125-41127).

EMD Chemicals also is seeking FDA approval to use the pearly pigments in cereals, candies, chewing gum and other foods. In June, FDA approved the use of titanium dioxide and mica pigments in some foods; the agency continues to review pigments made with synthetic iron oxide.

Click here for details of the regulation http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/E6-11536.htm.

Counterfeiting

PhRMA disputes number of U.S. counterfeit drug cases claimed by Canadian online pharmacy

An online Canadian pharmacy stated this week that while the U.S. government warns consumers that purchasing drugs from Canada may be risky, America has one of the highest numbers of counterfeit-drug cases in the world.

However, the Pharmaceutical and Research Manufacturers of America (PhRMA) ó which opposes Canadian firms shipping drugs to U.S. patients, claiming the practice is unsafe and illegal ó questioned the validity of the counterfeit figures.

DoctorSolve, an online pharmacy based in Surrey, Canada, claimed the U.S. was second only to Colombia in the number of cases involving counterfeit drugs. However, the company did not provide a source for this figure.

DoctorSolve also said FDAís own estimate is that each year 35 million prescriptions are filled with something other than the prescribed drug.

ìUntil thereís a better safeguard system in place in the (U.S.), Americans should know that buying online from a trusted pharmacy service can actually be safer than walking down the street to get meds from the neighborhood pharmacist,î Paul Zickler of DoctorSolve said in a statement.

FDA did not respond to United Press Internationalís (UPI) request for comment.

Alan Goldhammer, Ph.D., PhRMAís associate VP for regulatory affairs, told UPI that he questioned the information about the level of counterfeiting in the U.S.
 
ìI donít know that anybody has, as far as I know, published statistics in that area,î Goldhammer said. ìIím not sure that information exists,î he added.

Goldhammer said when new FDA regulations go into effect in December requiring drug distributors to provide documentation of the chain-of-custody of medications, Canadian firms would be unable to comply.

ìI donít know how any of these Internet sites could be in compliance with that,î he said, noting that they have to provide documentation tracing the source of their drugs back to a U.S. manufacturer.

Dianne Bidewell, a spokesperson for DoctorSolve, told UPI the release was issued to counteract the negative warnings about Canadian drugs.

ìWe just want to keep reminding people weíre right next to you, weíre taking those drugs too,î Bidewell said. ëTheyíre safe.î

So far, the negative campaigns in the U.S. about the possible risks of Canadian drugs have not dissuaded customers from using DoctorSolve.

ìAll itís done is angered the patients and itís put a bit of a delay in getting their order by about a week or two, and thatís about it,î Bidewell said.

She said large pharmaceutical companies, including Pfizer and Merck, have tried to shut down their shipments to the U.S. by limiting the amount of their drugs they will send to DoctorSolve each month. However, this has not hampered the pharmacyís supply, because it has simply gone elsewhere to obtain the medications.

ìWeíve had to go to other countries like New Zealand and Israel,î she said. Pharmacies in those countries will order the drugs from Europe and then send them to customers in the U.S.

Bidewell added that she thinks the pharmaceutical companies are driven only by concerns about their profits. ìThereís no other reason I can think of they would be against that because it is their meds,î she said.

As for FDAís motivation, she thinks the agency is being bullied by large pharmaceutical firms.

ìI think theyíve got pressure from the large pharmaceutical companies,î she said. ìI donít have any proof, but I canít understand the reasoning of holding back a personís medication because they think it will harm them, but on the other hand, the person is going to be harmed if they canít afford to buy the medication in the U.S., she said.

As it is, the amount of drugs purchased from Canadian pharmacies and shipped into the U.S. is probably only a tiny proportion of the total drug volume of the U.S. DoctorSolve has about 54,000 customers, and there are more than 250 other pharmacies in Canada offering a similar business.

But, more and more, people may be turning to Canada for their drugs, including young adults.

ìOur clientele is getting huge for birth control, because young people canít afford it in the U.S.,î Bidewell said.

FDA/HHS management

FDA, Barr to meet on Plan B; von Eschenbach, Senate committee spar at confirmation hearing

FDA and Barr Pharmaceuticals Woodcliff Lake, NJ, are scheduled to meet next week to discuss the companyís bid to sell its morning-after contraceptive Plan B without a prescription, the agency stated Aug. 2. This announcement came as Senate confirmation hearings got underway for Acting FDA Commissioner Andrew von Eschenbach, M.D., whose confirmation has been slowed by the political controversy over the agency implementing Part B.

In a letter to Barr July 31, FDA stated it was taking a new look at proposed sales of Plan B without a prescription. The agency said the pills would be kept behind pharmacy counters and women would need to ask for them. Women younger than 18 still would need a prescription.

FDA added it that it hoped to wrap up Barrís application, which has lingered at the agency since 2003, within weeks.

The pending decision over Plan B ó a set of two pills that can prevent pregnancy if taken within 72 hours of sexual intercourse ó has been controversial, with supporters and critics alike relentlessly lobbying FDA.

Part B came up almost immediately at von Eschenbachís confirmation, according to news reports. Von Eschenbach insisted Aug. 1 that ìmedical ideologyî not politics guided his handling of proposed over-the-counter sales of the morning-after contraceptive.

Senators hammered von Eschenbach about the timing and substance of a surprise FDA announcement that it would again consider expanding access to the emergency contraceptive known as Plan B. The announcement came on the eve of the confirmation hearing before the Senate Health, Education, Labor and Pensions Committee, and was the latest word in the three-year quest to widen access to the pill, made by Barr.
 
ìWe all know whatís going on here,î said Sen. Tom Harkin, (D-IA), a committee member. ìThis is a disregard for science out of ideological concerns.î

Von Eschenbach said he decided to consider allowing women 18 and older to buy the pills without a doctorís prescription ìnot on a political ideology, but on a medical ideology.î He said data did not support safe over-the-counter use by minors.

ìNo one told me what I should or could do. No one told me what decision I must and must not take,î von Eschenbach said during questioning.
FDA has been without a permanent leader for all but 18 months since Bush took office in 2001. Von Eschenbach has led the agency on an acting basis since September.

ìWithout a Senate-confirmed leader, we canít expect FDA to be as effective as it can be,î said committee Chair Mike Enzi, (R-WY). The committee did not vote on von Eschenbachís nomination.

Sens. Hillary Clinton, (D-NY), and Patty Murray, (D-WA), have placed a hold on the nomination until FDA makes a final decision on the emergency contraceptive. Clinton said the hold was intended to ìdraw a lineî against ìpoliticizing the FDA.î

ìThis is a slippery, dangerous slope we are on, doctor, and we are looking to you to make a decision,î Clinton told von Eschenbach.

Sen. Edward Kennedy (D-MA), the panelís ranking Democrat, called the pending Plan B decision ìa test case of FDAís integrity.î
If the announcement to meet with Barr ìleads to a swift and clear decision, I applaud it,î Kennedy said, ìbut we must make certain that the administration does not use it as yet another delaying tactic.î

Clinton raised the prospect that Bush might use a recess appointment to bypass the need for Senate confirmation. She asked the nominee if he would accept one before deciding on Plan B. Von Eschenbach responded that he wanted and looked forward to Senate confirmation.

Surgeon General Carmona to resign; HHS, White House mum on the subject

U.S. Surgeon General Richard Carmona said July 31 that he is stepping down, saying in a letter that he would judge himself successful if he had ìpersuaded one student to make good health choices or one mother to stop smoking.î

Carmonaís term expired over the weekend with no announcement from Department of Health and Human Services (HHS). But, a letter that Carmona wrote to his fellow officers at U.S. Public Health Service (PHS), announcing his retirement, began to circulate yesterday on Capitol Hill, and was obtained by the ìWashington Post.î

Carmonaís departure comes little more than a month after he issued a report highlighting the health dangers of secondhand smoke, which was most likely the hallmark of his tenure as the nationís 17^th surgeon general.

In his letter to PHS, Carmona wrote that he was returning to civilian life but provided no specific reason for his sudden departure. He simply cited his accomplishments while surgeon general, which included educating Americans about the importance of preparing for natural and other disasters. He also noted his focus on trying to eliminate health disparities among parts of the population on such diseases as AIDS and diabetes.

ìI think he was in a tough time,î Georges Benjamin, executive director of the American Public Health Assn, told the ìWashington Post.î

ìHere you have a guy who had significant experiences in preparedness and trauma and emergency care, and I wish we had used him more effectively in that role.î Prior to his nomination as surgeon general in 2002, Carmona was a trauma surgeon in Arizona.

Both HHS and the White House are mum about the departure. An HHS spokesperson, Christina Pearson, referred all questions about Carmonaís departure and potential successor to the White House; but White House spokesperson, Emily Lawrimore, said it would not comment on personnel matters.

FDA announces plans to strengthen advisory committee processes

FDA July 24 announced several steps to help make its advisory committee processes more effective at providing timely, top-tier, independent scientific advice to the agency and at reassuring the public about the basic integrity of this process.

This effort includes the development of guidances to provide greater clarity and transparency in the disclosure of waivers of relationships that could present the appearance of conflicts of interest, as well as additional efforts to implement more streamlined approaches that will improve the transparency in the appointment of members to the agencyís advisory committees.

FDA is taking these steps to make sure that it continues to have rigorous approaches in place that enable it to continue to recruit advisory members through a process that places the quality of scientific input sought by the agency as a top criterion.

ìThe advisory committee process is integral to examining the intersection between medical practice and clinical research, to spark debate about it, and to subject scientific work to close public scrutiny,î said Scott Gottlieb, M.D., FDAís Deputy Commissioner for Medical and Scientific Affairs. ìSome of the most valuable input often comes from people who are active practitioners but also heavily engaged in clinical research and we need to make sure that we continue to have the ability to recruit top clinical trialists.î

FDA believes it is crucial that the public have complete confidence in the integrity of the advisory committee process. Therefore, in the next few months, the agency plans to take the following steps to help ensure that our advisory committees continue to be scientifically expert and independent and that the advisory committee process is transparent:

• Issue a guidance identifying more clearly the conditions under which conflict of interest waivers are granted. Currently, for example, waivers can be granted to committee members under certain circumstances for participation in scientific endeavors related to the work of the committee, as well as for certain unrelated activities;

• Issue a guidance specifying when waivers of conflict of interest will be disclosed to the public and what information will be made available;

• Issue a guidance specifying when briefing materials used at advisory committee meetings will be made publicly available;

• Provide greater public dissemination of advisory committee schedules through increased mailings to public groups, and providing electronic notifications through an FDA advisory committee list serve and posting on FDAís web site; and

• Implementation of a more streamlined approach to the appointment of members to the agencyís drug-related advisory committees.

In addition, FDA previously announced that CDER is launching an internal assessment of its use and involvement with the advisory committee program of the agency. Led by senior management from the Advisors and Consultants Staff, within CDER, this comprehensive look at current advisory committee practices will include, among other things, the processes for choosing members with expertise specific to the meeting topic, the development of the agenda and questions for the Committee, and the preparation of background materials and presentations for the meeting.

The primary role of an advisory committee is to provide the agency with expert, independent advice on complex scientific issues presented to FDA. This advice contributes to the quality of the agencyís regulatory decision-making and strengthens the credibility of FDAís decision-making process by having public discussions of difficult scientific questions by leading experts, the agency staff and the agencyís stakeholders.

FDA remains committed to a transparent and effective advisory committee process to ensure that the agency and the public continue to benefit from authoritative expert scientific advice.

For more detailed information on this topic, please go to http://www.fda.gov/oc/speeches/2006/conference0724.html and for comments regarding an analysis of advisory committee voting, see http://www.fda.gov/oc/advisory/analysis.html.

Infectious diseases

HHS Secretary Leavitt joins Mayor Bloomberg at NYC Pandemic Planning Summit

New York City-Mayor Michael Bloomberg and HHS Secretary Mike Leavitt ó acknowledging that a possible flu pandemic would require a strong local response ó signed a resolution July 27 committing the city and federal government to planning efforts. They did so before an audience of public health officials, and business and community leaders, gathered to address pandemic flu preparedness.

In the planning resolution, HHS committed to providing guidance and technical assistance to New York City; financial assistance for planning, $8.2 million; and it agreed to review the cityís plans for use, storage and distribution of antivirals and notify it of its portion of the federal stockpile of pandemic influenza antiviral drugs.

New York City agreed to assure that its operational plan for pandemic influenza response is an integral element of the overall state and local emergency response plan and regularly communicate with relevant stakeholders to prepare. The city it also will notify HHS of the amount of additional pandemic influenza antiviral drugs it plan to purchase.

Leavitt and other top HHS officials have participated in more than 50 summits for states and territories, the agency said in a press release. HHS has also prepared tools to help with the planning process, including a state and local checklist, a business checklist, a guide for individuals and families, a checklist for schools, and a checklist for faith-based organizations. The guides were distributed at the NYC summit.

More information on pandemic flu readiness is available at http://www.pandemicflu.gov/.

Post-marketing studies

Most new drug approvals receive FDA requests for post-marketing studies: Tufts report

Phase IV studies are continuing to increase, and based on a Tufts Center for the Study of Drug Development (CSDD) study published Aug. 2, 73% of recent new drug approvals received FDA requests for post-marketing studies. The median cost of conducting these studies is also skyrocketing. Another costly and critical factor in conducting clinical trials, Phase I-IV, is the patient and investigator recruitment area, which is one the most time consuming and difficult tasks within drug development

Studies mandated by specific regulations for accelerated approvals, deferred pediatric studies, and the animal efficacy rule accounted for approximately one-third of the 492 post-marketing commitments (PMCs) performed during that time.

Although PMCs are not considered essential for approval, FDA will request, or require, them when it believes those studies can provide important data on the drug. In such cases, drug sponsors commit to conduct PMCs, which can yield additional information on drug effectiveness, safety and usage, product quality, and consistency in product manufacturing.

ìGiven widely shared concerns about the cost and time needed to develop drugs, and increased attention focused on the safety of newly marketed medicines, PMCs may help streamline premarket approval of drugs while aiding post-market identification of adverse drug events and other issues related to drug production and use,î said Tufts CSDD assistant director Christopher Milne, who conducted the analysis.

According to Tufts CSDD, the average cost to develop a new prescription medicine, from research and development through winning FDA approval, is $802 million. Drug developers then spend, on average, another $95 million per new drug to conduct post-approval R&D, which includes PMCs.

The Tufts CSDD study also found that:

• The number of PMCs per new drug increased from 2.7 in the 1970s to three in the 1980s, and then to 4.4 in 1998-03;

• The number of patients in PMCs has grown from a median of 30 in the 1970s to 123 in the 1980s. That number increased to 920 in the 1998-03 period;

• Efficacy-related and drug interaction studies outnumbered other study types in 1998-03; and

• Requirements for PMCs vary widely by FDA review division: 100% of all new anti-infectives approved in 1998-03 involved post-marketing studies, compared to 36% for analgesia, anti-inflammatory, and ophthalmic drugs.

Recalls/warnings

ìAt-homeî genetic tests may lack scientific validity or provide meaningful results only in the context of a full medical evaluation

FDA, the Federal Trade Commission (FTC) and Centers for Disease Control and Prevention (CDC) alerted consumers about the facts surrounding the direct-to-consumers marketing of genetic tests. According to FDA, which regulates the manufacturers of genetic tests, some of these tests lack scientific validity, and others provide medical results that are meaningful only in the context of a full medical evaluation.

FDA and CDC stated that because of the complexities involved in both the testing and the interpretation of the results, genetic tests should be performed in a specialized laboratory, and the results should be interpreted by a doctor or trained counselor who understands the value of genetic testing for a particular situation.

Read the complete MedWatch 2006 Safety summary, including links to further FDA and FTC supporting information, at http://www.fda.gov/medwatch/safety/2006/safety06.htm#Genetic.

WellPatch Cough & Cold Soothing Vapor Pads recalled for potential chewing danger

The Mentholatum Company, Orchard Park, NY, and FDA notified consumers and health care professionals Aug. 1 about a nationwide recall of WellPatch Cough & Cold Soothing Vapor Pads due to potential serious adverse health effects that could result if the product is ingested by a child removing the patch and chewing on it.

This product contains camphor, eucalyptus oil and menthol. Possible adverse events associated with chewing or ingesting products containing camphor or eucalyptus oils can vary from minor symptoms, such as burning sensation in the mouth, headache, nausea and vomiting, to more severe reactions, such as, seizures.

Read the complete MedWatch Safety summary, including a link to the firm press release, at http://www.fda.gov/medwatch/safety/2006/safety06.htm#WellPatch.

Berlex voluntarily recalls Ultravist Injection 370 mgI/mL

Berlex, Wayne, NJ, a U.S. affiliate of Schering AG in Germany, announced July 31 it is voluntarily recalling all lots of its X-ray contrast agent Ultravist Injection 370 mgI/mL (iopromide injection), as part of a worldwide recall, due to the potential that particulate matter in conjunction with crystallization may be present in the product.

This recall does not include other concentrations of Ultravist (150 mgI/mL, 240 mgI/mL, 300 mgI/mL). Berlex is undertaking this recall in consideration of the potential for serious safety problems if the product is administered to patients, including thrombosis of blood vessels, thromboembolism and injury or infarction of end organs, such as, the heart, kidney and brain.

Hospitals, imaging centers and other healthcare facilities should not use any Ultravist Injection 370 mgI/mL for patient care and should immediately quarantine any product for return.

ìPatient safety is our primary concern, and we are committed to taking the necessary steps in order to protect patients from any potential safety risks,î said Richard Nieman, M.D., VP and head of medical affairs for Berlex.

Berlex is undertaking this recall of Ultravist 370 mgI/mL due to the presence of particulate matter in conjunction with crystallization in consideration of the potential for thromboembolic safety problems if an affected product is administered to patients. On July 20, Berlex voluntarily recalled a single lot of Ultravist Injection 370 mgI/mL, 125 mL lot number 41500A (NDC 50419-346-12, EXP 01/2007) in the U.S. due to the presence of particulate matter in conjunction with crystallization.

While Berlex and Schering AG, Germany are investigating the situation, the company is taking precautionary action by initiating this recall. Berlex has informed FDA of its actions and maintains a close ongoing dialogue with the Agency.

As is standard practice, and per the Ultravist package insert, all parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, and should not be used if particulates are observed or marked discoloration has occurred.

High-strength hydrogen products not to be used for medicinal purposes

FDA warned consumers not to purchase or to use high-strength hydrogen peroxide products, including a product marketed as ì35% Food Grade Hydrogen Peroxide,î for medicinal purposes because they can cause serious harm or death when ingested.

FDA recommends that consumers who are currently using high-strength hydrogen peroxide stop immediately and consult their health care provider.

FDA has never approved high-strength hydrogen peroxide to be taken internally and considers hydrogen peroxide at 35% strength dangerous, even if handled according to the manufacturerís directions.

High-strength hydrogen peroxide ó more than 10 times stronger than the solution used in over-the-counter drugs to disinfect minor cuts ó is highly corrosive. Ingesting hydrogen peroxide can cause gastrointestinal irritation or ulceration. Intravenous administration of hydrogen peroxide can cause inflammation of the blood vessel at the injection site, gas embolisms (bubbles in blood vessels), and potentially life-threatening allergic reactions.

For more, go to http://www.fda.gov/medwatch/safety/2006/safety06.htm#Peroxide.

International

Indian pharmaceutical industry shows steady growth, RNCOS report states

The Indian pharmaceutical industry is fast on its road to healthy growth, according to an RNCOS market research report released Aug. 1. The Indian pharma sector was largely positioned as a generics market. But now it is transforming to emerge as major contributor in the global perspective.

The drive of the Indian pharma sector towards its greater share in the global industry is from its introduction of product patents in 2005. In the last 20 years, patents were only granted on processes decision. This being to the disadvantages of many multi-national companies, they exited from the country. However, it turned advantageous to India, which enabled it to become a leading producer of generic medicines.

ìRNCOS market research report, Opportunities in Indian Pharma Sectorî tells that the pharmaceutical sector in India currently shares U.S. $6 billion of the total $552 billion global pharmaceutical industry. And this share is poised to grow at a rate of 12% every year, compared to the annual growth of 8% in the world market. This is pointed evidence to the promising scenario of the pharmaceutical market in India.

The growth of Indian pharma industry is also driven by the low drug production costs, which are 55% lower than in the western countries. Another reason of high growth rates is the system of contract manufacturing.

The research report on pharma sector deals with certain critical issues and facts, which are:

• The emerging trends in the pharmaceutical sector in India;

• The key regulations and policy environment in the industry;

• The future scenario of the pharmaceutical market in India;

• The key players in this market in India;

• The opportunities in Indian pharma sector;

• The challenges faced by the industry; and

• Other economic factors affecting the market.

The RNCOS report is based on extensive research that provides objective analysis of Indiaís pharmaceutical sector performance. The report would be helpful for clients in analyzing the opportunities prevailing and critical for the growth of this market. It will also help investors who can refer to the detailed data and analysis on the changing dynamics of the pharmaceutical industry. The report is a valuable reference to all concerned with the Indian pharmaceutical industry and its marketing propensities.

Legislation

Senate committee approves legislation to restore grant eligibility for small biotech companies

The Senate Small Business and Entrepreneurship Committee has passed legislation that would restore Small Business Innovation Research (SBIR) grant eligibility to small biotech companies that are majority-backed by private investment.

In a statement, Jim Greenwood, President and CEO of the Biotechnology Industry Organization (BIO), thanked Sen. Kit Bond (R-MO) for his ìleadership in offering the amendment to the Small Business Administration reauthorization bill.î

ìI also want to express my appreciation to the other members of the Committee, particularly Chair Olympia Snowe (R-ME) and Sens. Mike Enzi (R-WY) and Maria Cantwell (D-WA) for their important contributions to achieve the compromise language included in the Bond amendment,î Greenwood stated.

Greenwood noted that the 20-year criteria for biotech firms receiving SBIR grants was changed in 2003, which in effect ìinequitably penalized biotech firms.î He added: ìPresently, companies that are 51% owned by a group of venture capital firms are not eligible for SBIR grants.î The amendment restores the original interpretation of eligibility by allowing more biotech and medical device companies to again compete for funding ó albeit limited ó to conduct research on innovative new medical therapies, ìproviding promise and hope for millions of patients and their families.î

CE marks

New ATS Open Pivot AP360 heart valve receives European approval

ATS Medical, based in Minneapolis, MN, July 31 announced the new ATS Open Pivot AP360 Mechanical Heart Valve has received CE approval for marketing and use in Europe, indicating its compliance with relevant European health, safety and environmental protection legislation.
According to the firmís statement, the ATS Open Pivot AP360 Heart Valve ìallows for a number of design enhancements that lead to particularly outstanding performance in all areas considered important to valve selection: implantability, hemodynamics, thromboresistance, durability and patient quality-of-life.î

It is based on the proven clinical foundation of the ATS Open Pivot Heart Valve that has been implanted in patients for more than 14 years. The ATS Open Pivot AP360 Heart Valve utilizes the same open pivot design, which has no recesses or cavities to promote formation of thrombus, and incorporates a strengthening band of MP35N, a cobalt-chrome alloy, providing ìexceptional compressive strength and durability,î the firm claimed. The flexible, flanged polyester cuff ìprovides improved suturability, flexibility and conformability, making even the most challenging implant easier,î the statement added.

ATS Medical President, CEO and Board Chair Michael Dale said, ìSurgeons have highly individualized and specific preferences regarding valve selection criteria, particularly with respect to implantability. With the ATS Open Pivot AP360 Heart Valve we have expanded on the fundamental strengths of the open pivot design. We have maximized hemodynamic performance while creating a cuff design that will extend our appeal to a broader spectrum of surgeons. We are excited to announce this next step in our plan to bring the open pivot design and performance to a larger worldwide audience of patients and surgeons.î

Manufacturing

Nektar abandons U.K. operations

Nektar Therapeutics announced Aug. 1 that it has closed its processing plant in Bradford, U.K. as it shifts its focus to developing its own drug products using its own drug delivery technology. In doing so, the U.S. company will no longer run any of its operations from the U.K. Thirty-five jobs were lost, the firm reported.

According to the companyís press release, the move comes ìas part of its ongoing strategy to realign business operations with a focus on product development using its leading drug delivery technologies.î Nektar had announced its intent to dispose of its U.K. operation and supercritical fluid technology on the companyís first quarter financial results conference call on May 10.

Previously, on Feb. 28, the company announced that Nektar U.K. at Bradford was deemed to be significantly impaired, which resulted in a write off, reported as part of the companyís 2005 net loss.

Robert Chess, chair and acting president, stated: ìAs Nektar transitions from being a technology development company to a commercial entity focused on achieving profitability, it is important that we channel our resources into those businesses that will drive future growth. To this end, disposing of our supercritical fluid processing technology represents a significant first step in aligning our spending with those activities that will drive our revenue in the near-term.î These include:

• Developing proprietary products based on our drug delivery technology;

• Exubera (insulin human (rDNA origin)) Inhalation Powder, the product of a developmental collaboration between Pfizer and Nektar, and diabetes life-cycle management products; and

• High-value partner programs.

Tri State Distribution, Milliken create wide-mouthed PP ISBM Packers for pill vial market

Tri State Distribution, Sparta, TN, one of the largest manufacturers of prescription pill containers and closures in the world, has developed what the firm calls ìa superior packaging product for the pharmaceuticals, vitamin and nutraceutical market,î according to an Aug. 2 statement.

The company is now marketing a clarified polypropylene-replacement bottle for both PET [polyethylene terephthalate] and HDPE [high-density polyethylene] bottles currently used to package vitamins, nutraceuticals and various moisture-sensitive OTC/HBA tablets and capsules. The new technology for ISBM PP packers offers significant advantages over the incumbents, including improved moisture barrier, a lighter-weight bottle and reduced cost, while maintaining the cosmetic advantages of its competitors including clarity, gloss and shine, the firm noted.

ìTo expand our companyís product offerings, we developed a clear polypropylene bottle with the look of PET and the inherent chemical and molecular properties of polypropylene,î said David Miceli, Tri State VP of sales.

ìThe new packers have the cosmetic advantages of the PET products, such as clarity, gloss and shine, but weigh less and have a much better moisture vapor transmission rate. This allows the U.S. to offer our customers a superior product at a reduced cost, and can significantly improve the shelf life for all solid tablets and capsules where moisture penetration can degrade the stability of the contents.î
 
Produced with a single-stage injection stretch blow molding (ISBM) process, the bottles contain two Milliken, Spartanburg, SC, additives, Millad clarifying agent and ClearTint colorants.

ìIn addition to the traditional amber found in this market, we were able to offer Tri State a full range of ClearTint colors,î said Alicia Stack, Millikenís global marketing manager for plastic colorants. ìAll colors can be formulated to block harmful UV light that can affect product performance and integrity. In addition, specific shades can be formulated to meet stringent USP transmission regulations.î

ìOur colored ISBM PP packers are practically indistinguishable from their PET counterparts,î added Miceli. ìThese containers work perfectly in high-speed automated filling systems, including labeling, capping and induction sealing.î

A full line of ISBM PP packers is available immediately, ranging from 75cc to 500cc with eight sizes in between. Tri State ISBM PP packers come in a wide range of transparent colors including blues, greens, reds, ambers and opaque colors such as gloss black and white. The packers offer customers an excellent opportunity to upscale their products without having to pay the higher costs associated with PET.

Tri State will continue developing this ISBM PP technology for use in other industries such as personal care products, household chemicals and other product categories. The superior MVTR performance with clear PP makes these bottles ideally suited for any product ó solid, liquid or powder ó that requires protection from moisture.

Millikenís Millad 3988 is a market-leading clarifying agent for polypropylene, the company claimed. In addition to providing the highest level of clarity currently available in PP, Millad contributes to product strength and rigidity while improving manufacturing productivity by increasing crystallization for reduced cycle times.

Created to work specifically with clarified PP, ClearTint colorants provide the brightest, cleanest and most transparent colors available for polypropylene. The unique colorant technology offers deep, rich shades unavailable with traditional pigment colorants. ClearTint colorants are also FDA compliant, non-migrating and non-extracting, unlike some dyes on the market.

New Steam-Thru II Connection from Colder provides sterile connection between disposable systems

Colder Products Company, St. Paul, MN, a provider of single-use connections for the bioprocessing and pharmaceutical markets, introduced Aug. 2 the Steam-Thru II, which provides a sterile connection between disposable systems and existing stainless steel processing equipment.
The development of the Steam-Thru II Connection is a direct response to customer requests for ìsteam offî capabilities to our existing Steam-Thru product line,î said John Boehm, business unit manager for bioprocessing markets at Colder. ìThe ìsteam offî functionality combined with the no ìdead legî design reduces the chance for cross-contamination and provides greater process flexibility.î

Steam-Thru II features a patented 3-port design that allows it to be mounted directly to hard-plumbed systems to create a sterile connection for single-use feeding, harvesting and sampling systems. Steam-Thru Connections increase operational efficiency by decreasing process downtime and costs related to cleaning and cleaning validation associated with reusable components, the firm stated.

An extensive test program has been completed in support of customer validation. Microbial ingress testing was done at Northview Laboratories and bacterial challenge testing was completed at the University of Minnesotaís Biotechnology Resource Center. Biocompatibility testing on the materials of construction was performed by NAMSA Laboratories, Northwood, OH.

Colder Steam-Thru II Connections offer industry standard sanitary terminations and are available in three-fourth inch and 1.5-inch tri-clamp. Hose barbs connect to half-inch ID tubing. Polysulfone body components and silicone, platinum-cured, USP Class VI seals meet industry material-compatibility requirements. Operating temperatures range from 4ƒ C (39ƒ F) to 40ƒ C (104ƒ F) in flow position and up to 135ƒ C (275ƒ F) for 60 minutes in steam position. Pressure ranges from vacuum to 20 psi at 1.38 bar in flow position and up to 35 psi at 2.41 bar in steam position.

Southwood Pharmaceuticals implements raining data ePedigree compliance solution

Raining Data, Irvine, CA, announced Aug. 1 that Southwood Pharmaceuticals, Lake Forest, CA, has successfully implemented Raining Dataís ePedigree Compliance Solution to enable regulatory compliance and to improve supply chain visibility and security.

By enabling all of the workflows and master data management for Pedigree Compliance, Raining Dataís XML-Centric ePharma Software allows Southwood Pharmaceuticals to be compliant with Florida, California and Federal Pedigree requirements while optimizing their business operations, the company stated in a press release.

ìRaining Dataís XML-Centric platform enables our business to be agile and flexible in an environment of rapidly changing regulatory compliance requirements. Their ePharma Software was compatible with our existing processes and facilitated our business requirements for information management,î said Cliff Scott, IT Development Director for Southwood Pharmaceuticals.

Southwood Pharmaceuticals leverages the solution to manage pedigree supply chain orders, maintain a segregated inventory of pedigree products, receive-authenticate-create-sign-ship pedigrees and provide a complete chain of custody audit trail for drugs in their distribution network. Southwood Pharmaceuticals also uses the solution in their warehouse to receive and authenticate drugs shipments. As a result, the company can realize savings by integrating the ePharma functions into their existing operations to ensure availability of pedigree drugs and increase security to deter illegally imported and counterfeit drugs from entering their distribution network.

People

FDA selects Parks as new director for Division of Metabolic and Endocrine Products

FDA announced July 28 the selection of a new director for the Division Of Metabolic And Endocrine Products (DMEP) in ODE II, Mary Parks, M.D. Parks will become the official Director of DMEP on Aug. 6.

An agency press release stated that ìParks has been doing a great job serving as the Acting Director since [the previous directorís] departure from FDA in January. We are very pleased to have her continue in that role in the official capacity.î

FDA noted that Parks is a highly qualified physician with a metabolic and endocrine background. She did her undergraduate college education at Georgetown, with undergraduate medical training first at Tufts, but graduating from Georgetown. She did an internship and residency in internal medicine and her endocrine and metabolism fellowship at Georgetown, with additional post-doctoral training at the Johns Hopkins University School of Hygiene and Public Health during her years at FDA.

VioQuest Pharmaceuticals appoints Giles to chair of scientific advisory board

VioQuest Pharmaceuticals, Basking Ridge, NJ, a biopharmaceutical company focused on acquiring, developing and commercializing targeted cancer compounds, announced Aug. 2 it has appointed Francis Giles, M.D. of the University of Texas MD Anderson Cancer Center to its scientific advisory board as chair.

Giles currently is the professor of medicine and chief of the section of developmental therapeutics at the department of leukemia at MD Anderson where he focuses specifically on developing novel therapies for patients with hematological malignancies. He also serves as co-chair of the Division of Cancer Medicine Phase I Group.

Daniel Greenleaf, VioQuestís CEO, said, ìGilesí broad knowledge of utilizing targeted agents for cancer therapy is a perfect match for VioQuest, since we are currently conducting clinical trials for two targeted oncology drugs. He will be an exceptional addition to our prestigious SAB, which includes Webster Cavanee, M.D., Kenneth King, M.D., and Praveen Tyle, M.D.î

Conferences

ExpertBriefings.com audioconference: FDAís Final Compliance Policy Guide for Marketed Unapproved Drugs ó Is Agency Enforcement at a Crossroads, or Stuck in a Traffic Circle? Aug. 10, 2-3:00pm (EST). Our speaker, Kurt R. Karst, an attorney with Hyman, Phelps & McNamara, P.C. in Washington will describe the different ìcategoriesî of drugs that are currently marketed in the U.S., and FDAís regulations and policies concerning the marketing of unapproved prescription drugs. In particular, the presentation will focus on FDAís recently issued final Compliance Policy Guide, which describes FDAís enforcement policy for taking action against companies marketing unapproved new drugs. For more information, or to register, visit http://www.fdainfo.com/expertbriefings/ or call (703) 779-8777.

PDA: Basic Concepts of Cleaning and Cleaning Validation, Aug. 7-8, St. Louis, MO. This course is designed for personnel in pharmaceutical manufacturing and addresses the practical aspects of meeting FDA cleaning validation requirements. The course will provide an introduction to basic issues in cleaning and cleaning validation, integrate various aspects of the cleaning process and provide attendees with alternatives to improve the quality of their cleaning programs. For more information, go to http://www.pda.org/calendar/Courses/stlouistraining/381.htm.

PDA: Root Cause Investigation for CAPA, Aug. 7-8, St. Louis, MO. This course will provide participants with a proven investigational methodology. They will also be introduced to TQM and Six Sigma tools, which are essential for the problem solving process. Participants will learn to apply a seven step investigational methodology to determine the root cause of a technical CAPA problem and implement an effective corrective action to restore the original product or process performance. For more information, go to http://www.pda.org/calendar/courses/stlouistraining/576.html.

4^th Annual Pharmaceutical Leadership Forum, Sep. 10-11, Philadelphia. This senior executive forum will provide an integrated approach to tackling the industryís critical issues. For more information, visit http://www.pharmaleadershipforum.com.

2006 PDA/FDA Joint Regulatory Conference, Sept. 11-15, Washington. Industry executives, academics and authors will come together with FDA representatives at the 2006 PDA/FDA Joint Regulatory Conference to discuss what steps need to be taken to improve the performance of the industry. For more information, go to http://www.pda.org/pdafda2006.

MDRs and Global Adverse Event Reporting, Sept. 13-14, Doubletree Hotel, Washington. Sponsored by AdvaMed in cooperation with FDA. Some of the pertinent issues to be discussed include implementing medical device reporting (MDR) requirements, MDRs and the link to inspections and enforcement actions, health hazard analyses, global device adverse event reporting systems, and industry experience with uniform global reporting. For more information, visit http://www.advamedmtli.org/mtli/mtg06-35.cfm.

6^th Pharma & Biotech Competitive Intelligence Summit, Sept. 18-19, Princeton, NJ. Sponsored by SRI Institute, network with key industry influencers in an executive peer-to-peer setting. For more information, visit http://www.srinstitute.com/ci.

Process Validation Requirements & Industry Practice, Sept. 25-27, Washington. Sponsored by Assn for the Advancement of Medical Instrumentation, this program will provide regulatory affairs experts, quality systems professionals, manufacturing engineers and process development engineers with the knowledge and skills needed to comply with the process validation requirements of FDAís Quality System regulation while offering information on how to implement an effective validation program. For more information, go to http://www.aami.org/meetings/courses/pv.html.

CDER Forum for International Drug Regulatory Authorities, Sept. 25-28, Rockville, MD. For more information, visit http://www.fda.gov/cder/audiences/iact/forum/forum_200609.htm.

Medical Technology Software Conference, Nov. 8-9, Doubletree Rockville Hotel & Executive Meeting Center, Rockville, MD. Sponsored by AdvaMed. Some of the pertinent issues to be discussed include software validation, international software lifecycle standards, AAMI technical information report on software risk management, and EU regulation of medical device software. For more information, visit http://www.advamedmtli.org/mtli/mtg06-33.cfm.

Drug/Device Summit 2006, Dec. 4-5, Hyatt Regency, San Diego. The Biotechnology Industry Organization and BIOCOM, in partnership with Windhover Information, Inc. and AdvaMed), will bring together the key stakeholders in biotechnology, pharmaceutical and medical device companies working to develop combination products and therapies, as well as leading investors in the industry. Plenary sessions will be offered on trends in the health care convergence industry, with special focus on successful partnering strategies, criteria for strategic and corporate investors and modernization in the combination-product approval process. In addition, there will be formal and informal networking opportunities with industry CEOs, investors and prospective partners. For more information visit, http://drugdevice.bio.org/opencms/summit/2006/index.jsp.