Genzyme’s Friday the 13th

Erik Greb PharmTech editorFriday the 13th was an unlucky day for Genzyme (Cambridge, MA). On that day, the company and the US Food and Drug Administration alerted healthcare providers that stainless steel fragments, nonlatex rubber, and fiberlike material had been found in products filled at Genzyme’s Allston Landing manufacturing facility. The enzyme-replacement products Cerezyme, Fabrazyme, Myozyme, Aldurazyme, and Thyrogen were affected. FDA advised that visual inspection and filtration of the products should reduce the risk of administering contaminated medicines to patients. Read more »

FDA Begins Enforcing Deadlines on Form 483 Responses

Maribel Rios PharmTech editorGot a Form 483? Then you’ve got 15 days. Starting today, FDA will enforce its program that calls for a more timely review of its Form 483 Inspectional Observations. Under this program, a company has 15 days to respond to the observations cited in the agency’s Form 483, before the agency decides whether to issue an official warning letter. The goal of this program is to optimize FDA’s already strained resources and to move firms to promptly correct noted violations. Read more »

Mylan-FDA Showdown

Angie Drakulich PharmTech editorIt’s all over the pharma blogs. Generic drug manufacturer Mylan (Pittsburg, PA) and FDA almost had a showdown.

The Pittsburgh Post-Gazette reported on July 26 that workers at Mylan’s Morgantown, West Virginia, plants were “routinely overriding computer-generated warnings about potential problems with the medications they were producing.” Workers in all three shifts of the plant’s operations were allegedly involved.  Read more »

Are Facility Inspections a Zero-Sum Game?

Erik Greb PharmTech editorPerhaps out of embarrassment at the stream of incidents involving contaminated products, the US Food and Drug Administration has requested the largest budget increase in its history. The agency intends to use part of the funds for its proposed Safer Medical Products initiative, which will scrutinize domestic and imported drugs. Will it use the money wisely? Read more »

Shared Inspection Process for APIs Falls Short

Patricia Van Arnum PharmTech editor Speaking at the European Union Health Minister Forum this week in Angers, Anjou, France, Michael Leavitt, Secretary of the US Department of Health and Human Services and chair of the Interagency Working Group on Import Safety, pointed to a pilot program for joint inspections between the United States, the European Commission, and Australia, He called the program “the beginning of what we hope will become a new way of doing business.” Read more »

The Right to a Safe Trial

Erik Greb PharmTech editorNormally, I don’t think much about research and development. I usually leave that subject to our sister magazine, Applied Clinical Trials. I do think about patient safety, though, and today an announcement on the website of the US Department of Health and Human Services (DHHS) got my attention.DHHS’s Office for Human Research Protections (OHRP) is soliciting public comment about a proposal to issue guidance recommending training for personnel who conduct, review, or oversee human clinical trials. I was surprised that such training was not already formalized.When I read a little more, I was even more surprised. Read more »

Is a PDUFA Model Appropriate for Inspection Fees?

Patricia Van Arnum PharmTech editor Congressional hearings began this week on the Food and Drug Administration Globalization Act discussion draft. An important thrust are measures for creating parity between inspections of domestic and foreign drug-manufacturing facilities and to use registration fees of these facilities to help fund FDA’s inspection process. Read more »

House Measure Provokes More Debate on Regulatory Oversight of Imported Drugs and APIs

patricia van arnum editor pharmtechThe issue of drug safety of imported drug products and active pharmaceutical ingredients (APIs) took center stage this week when the US House of Representatives Committee on Energy and Commerce proposed measures that would require country-of-origin labeling of APIs, parity between foreign and domestic inspections of drug-manufacturing facilities, registration fees to finance the cost of inspections, and annual registration of drug-manufacturing facilities operating in the US or exporting products to the US. Read more »

Industry Doubts About Harmonization

drakulich.jpgI attended a session this morning at Interphex 2008 and the speaker pointed out that there are clear doubts among industry about harmonization. Will all three regions–the US, Europe, and Japan–really be able to pull off this massive effort? Industry doubts about harmonization have been around since, well, the idea of harmonization was introduced, but what is interesting to consider, is, does it matter? If FDA is fully behind harmonization and QbD, specifically ICH Q 8, Q9, and Q10, it may not matter whether or not Europe and Japan are also on board.

One case in point, I recently toured a manufacturing facility overseas that’s about half-way built. They have had a few inspections already and are gearing up for more before they become fully operational. I asked the manager which inspection he was most fearing–FDA’s, the UK’s, or any of the other national inspectors that may be stopping by to take a look around. He answered, “Well, FDA’s inspection is really the only one that matters.” And this was coming from a UK company at a UK plant.

If this is the feeling among plant managers worldwide, how important is harmonization? Now I’m not trying to downplay the importance of harmonization–in fact, I fully support it. In this global industry, global collaboration is a must. But playing devil’s advocate for a minute here, what if everyone just followed FDA’s rules and took its approvals or nonapprovals as final word?

Is Regulating Offshore Manufacturers Truly Good Public Policy?

Patricia Van Arnum Pharmtech editorThe recent announcement by the US Food and Drug Administration that it was setting up an office in China (see ePT story,”China, Here We Come”) was welcomed by many in the pharmaceutical industry. Read more »

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