The NIH is responsible for maintaining the public database of drug trial results, while the FDA is responsible for enforcing the statutory drug trial reporting requirements.
The law "was enacted in response to similar reporting failures that contributed to dangerous or ineffective drugs remaining on the market far longer than they should have," the letter points out. "The new study suggests this underreporting is continuing today."
The letter was signed by Reps. Henry Waxman (D-Calif.) and Edward Markey (D-Mass.), the top Democrats on the Energy and Commerce and Natural Resources committees, respectively, and Rep. Diana DeGette (D-Col.), ranking member on the Energy and Commerce oversight subpanel.