The FDA should have the power to mandate recalls, subpoena witnesses and documents, and destroy at the border any products that pose a public safety risk. So says Pew Health Group in a just published report, After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs.
"Congress must institute reforms to ensure that the FDA's oversight of overseas manufacturing is increased, and that industry is held accountable for the security and safety of increasingly globalized and outsourced supply chains."
The Pew recommendations are similar to those advocated by President Barack Obama in his appeal to Congress in March to protect U.S. intellectual property. "We recommend legislative changes that require importers and manufacturers to notify the FDA when they discover counterfeit drugs...and [to] adopt a track-and-trace system for pharmaceuticals and related products."
The Pew report, which runs 115 pages, provides more in the way of specifics than Obama did, whose recommendations were part of a larger effort to protect IP. The Pew report notes the lack of a "national system for tracing the provenance of finished drugs as they are bought and sold," and that drug pedigrees and wholesaler licensing requirements vary widely among states. "Drug distribution tracking and regulation must be improved...and a universal system should be implemented."
"Legislators, the FDA, consumer organizations and industry recognize the need to strengthen control of the pharmaceutical supply to safeguard public health," the report continues.
It's unclear whether Congress is embracing any of the recommendations from Obama or Pew for measures that aim to protect all Americans from fake and substandard drugs. One promising sign was Sen. Sherrod Brown's letter to Margaret Hamburg in which he queries the commissioner on the extent of FDA's authority when inspectors are turned away from foreign manufacturing facilities.
Less promising are the recent activities of some members of Congress, notably Fred Upton and members of his House Energy and Commerce Committee. Among them are the committee's investigation into the contaminated heparin case of 2007-2008, due to Upton's dissatisfaction with the FDA's tracing of it only as far as exporter Chongqing Imperial, and his seeming desire to continue a public browbeating of Hamburg. In letters disparaging the FDA's effort to solicit information from both drugmakers and Immigration & Customs Enforcement, Upton explains, "We believe there is substantial public interest in solving this case."
Then there was the congressional probe of both Johnson & Johnson and the FDA concerning the Tylenol recalls. And of course the ongoing talk of the amount by which it wants to cut the FDA's budget while adding to the agency's workload. And let's not forget Sen. Al Franken's recent letter to CDRH director Jeff Shuren emphasizing the need for medical device manufacturers to have a say in the revisions to the device clearance process. That's a Congress pretty well involved in certain pet affairs at the FDA.
But a concerted effort to develop a national track/trace system to thwart counterfeiters and protect Americans? It might be time to recheck priorities.
I believe there is substantial public interest in a secure drug supply. - George Miller