By Kurt R. Karst –
It was 50 years ago today (October 10th) that President John F. Kennedy signed into law the Kefauver-Harris Amendments of 1962, Pub. L. No. 87-781, 76 Stat. 780 (1962), which amended the 1938 FDC Act to require, among other things, proof of the effectiveness of a drug product before approving it. FDA has been celebrating the anniversary with some wonderful historical information and storyboards (see here).
The Kefauver-Harris Amendments forever changed the way new drugs are approved and regulated in the United States. Like many significant changes to the FDC Act, the Kefauver-Harris Amendments were prompted by a tragedy. In 1961, as FDA was reviewing an NDA for the sedative drug KEVADON (thalidomide) for morning sickness, reports surfaced from Europe where the drug was approved that thousands of children whose mothers were taking the drug during pregnancy were born with severe birth defects. The thalidomide tragedy fueled the passage and enactment of the 1962 Drug Efficacy Amendments. (Coincidentally, October 11th is the 75th anniversary of the date on which the American Medical Association received a report of several deaths caused by Elixir Sulfanilamide, which led to the enactment of the FDC Act in 1938 requiring that new drugs be show safe.)
Fast-forward 50 years and we once again find ourselves faced with a tragedy – an outbreak of fungal meningitis caused by a reportedly contaminated injectable steroid prepared (see here and here). According to press reports, the contaminated injectable has already resulted in more than 10 deaths (and more than 100 confirmed cases). And, not surprisingly, there have been calls for changes to the law. Although what’s different this time is that 50 years ago FDA lacked specific legal authority to require proof of efficacy; in 2012, FDA would assert that it has the authority to take action against compounders, but uses it only at its discretion.
For years, FDA has struggled to establish an enforcement mechanism with respect to compounded pharmaceutical products that passes muster with Congress and the courts, as well as with FDA’s own resource constraints. We won’t recount the long history of compounding here, or FDA’s enforcement (or non-enforcement) of its compounding policies. We note, however, that there have been several cases in recent years, including the Franck’s Lab compounded veterinary drug case – see here – and the recent lawsuit over MAKENA and compounded 17p – see here – that show an inconsistent FDA posture. Under current FDA policy (Compliance Policy Guide 460.200 - Pharmacy Compounding), the Agency does not permit pharmacy compounding of drugs that are commercially available and approved by FDA, but exercises discretion in deciding whether or not to take enforcement action. Perhaps the breadth of FDA’s assertion of authority was best expressed in the Franck’s Lab case, where the Agency contended that the 1938 FDC Act prohibits all pharmacy compounding, which industry practice has continued only as a matter of FDA’s unreviewable enforcement discretion. Thus, according to FDA, when Congress enacted the FDC Act in 1938, it “quietly criminalized” all pharmacy compounding practices, yet had exercised enforcement discretion for decades. At the same time, FDA has acknowledged that pharmacy compounding is medically essential. Hyman, Phelps & McNamara, P.C. Director Jeff Gibbs discussed FDA’s oversight of compounding pharmacies and the current tragedy on The Diane Rehm Show on October 10th (see here).
Enter the legislators . . . .
Now that compounding is front page news, there are calls from Congress to strengthen FDA’s oversight of compounding pharmacies. Multiple letters were sent to FDA earlier this week saying that there is a clear and present need for stronger accountability and oversight, and querying the Agency about current regulations and oversight practices, including letters from Senator Richard Blumenthal (D-CT) (here) and Representative Ed Markey (D-MA) (here).
But that was only the beginning. Several members of the House Energy and Commerce Committee have now requested an investigation and hearings on the meningitis outbreak. The calls for legislative reform are also streaming in. Reps. Markey and Rosa DeLauro (D-CT) have separately stated their plans (here and here) to introduce legislation to require greater oversight by FDA of compounding pharmacies. Public Citizen has also entered the fray, saying in a press release that “Congress should conduct an investigation into this tragic situation and hold oversight hearings as soon as possible,” and that “Congress should act immediately to pass legislation” if there are holes in FDA’s existing legal authority.
We’re likely to see increasing interest in and calls for legislation as the fallout from this tragedy builds.