On Jan. 4, President Obama signed the FDA Food Safety Modernization Act. The bill expands FDA’s oversight of the food industry and grants the agency, among other things, the authority to issue mandatory food recalls (see back story).
PharmTech is asking readers in our current poll whether FDA should have the same power over pharmaceutical recalls. Right now, nearly 90% of respondents have said “Yes.”
We asked the same question back in June 2010, after US House Oversight and Government Reform Committee Chairman Edolphus Towns announced in his closing statement at the first hearing on Johnson & Johnson’s children’s medicines recall that he planned to introduce legislation to give FDA mandatory recall authority. At that time, 72% of respondents thought that the agency should have the power to do so.
Our current poll has about the same number of respondents as the poll from June. It will remain open until Wednesday, so the 90% majority could change. Perhaps the final results will be similar to those of last year’s poll. Or perhaps opinions are shifting in favor of allowing tighter regulation by FDA. Could J&J’s recent massive recalls have changed people’s minds? Luckily, the company’s widespread recalls of its over-the-counter products were, as the company states in most of the recall notices, “not being undertaken on the basis of adverse medical events,” and that the possibility of such events is remote. Perhaps to protect the safety of the OTC and pharmaceutical drug supply, FDA should have more power.
US House Reps. John D. Dingell, chairman emeritus of the Energy and Commerce Committee; Henry A. Waxman, chairman of the Energy and Commerce Committee; Frank Pallone, chairman of the Subcommittee on Health; and Bart Stupak, chairman of the Subcommittee on Oversight and Investigations introduced last December H.R. 6543, The Drug Safety Enhancement Act, which would expand FDA’s authority to provide it with more resources to ensure drug safety. One provision of the bill would give FDA new enforcement tools, such as mandatory recall authority, increased civil and criminal penalties, and new FDA authority to subpoena records related to possible violations of supply-chain safety.
“In recent years, our domestic drug supply has become an increasingly globalized one,” Rep. Waxman said in an announcement of the bill. “Unfortunately, FDA lacks the proper authorities and enforcement tools to help fully protect us from the new threats posed by this system, as illustrated by the heparin catastrophe of 2007. This legislation will provide the tools and resources the agency needs to do just that.”
Cast your vote in PharmTech’s current poll, and feel free to comment below why you voted for or against granting FDA drug-recall authority.