The welter of recent product recalls (and phantom recalls) initially got the US Congress talking about the adequacy of Johnson and Johnson’s (J&J, New Brunswick, NJ) manufacturing and quality-control operations. But lawmakers soon began asking questions about our line of defense against potentially harmful products: the US Food and Drug Administration. Read more »

Publicity about substandard or contaminated products usually lights a fire under pharmaceutical companies, which then race to address their compliance problems. But a new US Food and Drug Administration inspection report shows that, despite a stream of product recalls and a Congressional investigation, Johnson & Johnson (J&J, New Brunswick, NJ) has not gotten its house in order yet. And the company’s latest problems conceivably could make things hot for one of its partners. Read more »

Friday 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 »

Got 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 »

It’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 »

Perhaps 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 »

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 »

Normally, 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 »

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 »

The 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 »