Bill would give FDA mandatory recall powers
pharmafile | July 27, 2010 | News story | Manufacturing and Production |Â Â FDA, manufacturing compliance, recallsÂ
The chairman of the US congressional committee investigating the quality control problems at Johnson & Johnson, Edolphus Towns, has introduced a bill that would give the FDA the authority to order recalls of human and animal drugs.
At the moment the US regulator can only request a voluntary recall of a medicine that it deems is a risk to patient safety. Bill HR 5740 will extend those powers to allow it to request either a voluntary or a mandatory recall of adulterated or misbranded drugs.
It also spells out that it is the responsibility of the manufacturer to notify the FDA of any problems with medicines and communicating the identity and location of medicines in the supply chain. At present there is a requirement for companies to inform the FDA within three days of receiving information that a product may be faulty.
The bill would also allow the FDA to call an immediate halt to the distribution of medicines if it believes there is a risk of “adverse health consequences or death to humans or animals”.
In case of either a mandatory cessation of distribution or recall, the affected company will have a 24-hour period to appeal, with an informal hearing convened to weigh up the case no later than five days later.
Towns had already suggested he would file such a bill in the first committee hearing to examine the nationwide recall of thousands of paediatric medicines by J&J’s McNeil Consumer Healthcare division.
One key element emerging from that hearing was the contention that J&J had embarked upon an alleged ‘phantom’ recall of one of its Motrin products, hiring contractors to buy up the affected product as part of a test purchasing programme in order to avoid having to announce a formal recall.
The company has also been scrutinised for delaying the recall of some other products.
The Bill was introduced in the House of Representatives on July 14 and referred to the Committee on Energy and Commerce.
Phil Taylor
Related Content
Johnson & Johnson submits robotic surgical system for De Novo classification
Johnson & Johnson has announced the submission of its Ottava Robotic Surgical System for De …
MedPharm announces US FDA inspection of North Carolina manufacturing facility
MedPharm has announced that the US Food and Drug Administration (FDA) has completed a successful …
Rethinking oncology trial endpoints with generalised pairwise comparisons
For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival …
