Shutdown Forces FDA, HHS No-Shows

Officials from FDA and the National Institutes of Health (NIH) were scheduled to explain developments in clinical trial registration and transparency at the Drug Information Association’s conference on Clinical Trial Disclosure in Bethesda, Md. this week. They sent in slides, and one HHS official even pre-recorded his presentation. But the government shutdown kept them from showing up in person.

Read more »

Pooling Resources to Strengthen Supply-Chain Security

Amy RitterWith around 80% of APIs manufactured outside the US, many in developing nations without strong regulatory oversight, ensuring the quality and safety of the US’s drug supply is a herculean task. FDA has already taken steps to increase the number of overseas inspections, but it is impractical to assume that one agency is capable of inspecting the world’s manufacturing operations on its own. The Institute of Medicine released a report on Apr. 4, 2012 outlining several practical steps that FDA could take to strengthen supply-chain security. Read more »

Could Ben Venue’s Manufacturing Suspension Have Been Avoided?

Erik Greb PharmTech editorWhen only a handful of manufacturers supply a given drug, production problems at any of those companies can lead to a shortage. Earlier this year, problems at Ben Venue’s Bedford, Ohio, site contributed to shortages of the cancer drug Doxil. The shortages are likely to continue now that Ben Venue has suspended manufacturing at the plant. Read more »

Let’s Be Friends In Regulation

Stephanie Sutton Pharm Tech EuropeThere’s a lot of activity between the EMA and the FDA at the moment. Recently, reports have been published following two international pilot programmes regarding API inspections and good clinical practices (GCP). The outcome of the pilots? Success! Read more »

Diligence Is Our Due

Erik Greb PharmTech editorIn 2010, the US House of Representatives’s Committee on Oversight and Government Reform held two hearings after scandalous cGMP violations at McNeil’s Puerto Rico facilities came to light. Former FDA Deputy Commissioner Joshua Sharfstein told the Committee that the agency would review McNeil’s plan for correcting deficiencies to ensure that the corrective actions were effective. “FDA intends to keep a close eye on these facilities until the company earns our confidence back,” said Sharfstein. Read more »

Consent Decree (Finally) for J&J

Erik Greb PharmTech editorBeginning in September 2009, I watched with increasing surprise as Johnson & Johnson (J&J) recalled more and more of its products. As the recalls kept coming, my surprise turned to amazement that some of the company’s facilities (particularly the one at Fort Washington, Pennsylvania) could have been maintained and run in such an apparently haphazard way. As time went on, my amazement ebbed, and the continuing stream of recalls elicited little more than a shrug. Read more »

Lethal Injections and Foreign Inspections

Erik Greb PharmTech editorWhen Hospira stopped manufacturing sodium thiopental, which is used in lethal injections, it caused a drug shortage, and states began looking for alternate suppliers. At first, the developments made me wonder whether FDA should oversee nonmedical uses of drugs. Now the shortage has led to a federal lawsuit that raises questions about the way the agency controls imported drugs. Read more »

Memo to Congress: Hands off FDA

Erik Greb PharmTech editorIn January 2011, control of the US House of Representatives will shift to the Republican party. Reducing the federal deficit is one of the party’s top priorities, and Republican leaders have proposed to cut domestic spending as a means to accomplish this end. But should all programs be put on the chopping block? Read more »

FDA Needs More Muscle and Money

Erik Greb PharmTech editorThe 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 »

J&J and Guilt by Association

Erik Greb PharmTech editorPublicity 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 »

Next Page »