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.
Many legislators and citizens at large believe that FDA would be better able to protect public health if the agency had more muscle. Last Tuesday, Senator Michael Bennet (D-CO) introduced the Drug Safety and Accountability Act of 2010, which would give the agency valuable tools. The bill would grant FDA the authority to assess civil penalties for violations of the Food, Drug, and Cosmetic Act and to subpoena documents and witnesses. In a section that reflects J&J’s problems, the bill also would require FDA to consider over-the-counter drugs as risky as prescription drugs for the purposes of manufacturing-site inspections. These clauses would give the agency more teeth and likely influence drugmakers’ operations as well.
Bennet’s bill follows hot on the heels of H.R. 5740, which Representative Edolphus Towns (D-NY) introduced in July. Towns’s bill would enable FDA to order recalls of drugs it suspects are adulterated or misbranded and would pose threats to patients’ health. I believe that the agency should have had this authority long ago. We may trust many pharmaceutical companies to issue voluntary recalls when they accidentally create substandard products, but FDA cannot protect us from careless or unscrupulous behavior without the ability to order recalls.
Now, it’s all well and good to demand more from FDA, but the agency needs personnel and resources to perform the tasks Congress gives it. The Government Accountability Office and the Institute of Medicine have concluded that FDA faces serious funding deficits that prevent it from fulfilling its mandate. That’s why I’m glad that Representative Henry Waxman (D-CA) and Senator Tom Harkin (D-IA), among other lawmakers, have asked Kathleen Sebelius, secretary of the US Department of Health and Human Services (HHS), to tell Congress what FDA requires to protect American consumers. The Congressmen want to be sure that HHS’s budget request will enable them to allocate sufficient funds to FDA in fiscal year 2012.
We should cheer legislators’ efforts to strengthen FDA’s regulatory abilities. But we also should urge them to give the agency the resources it needs. Secretary Sebelius is in the best position to ensure that FDA can protect us from problems such as the J&J recalls. If she assesses the agency’s needs well enough, she might even help FDA to prevent similar problems in the future.