According to reports, the Republicans want to roll back new conflict-of-interest rules they say are depriving the Food and Drug Administration of needed expertise from the drug industry and they want the FDA bill to boost the drug industry’s role. Democrats, meanwhile, are focusing largely on the safety of imported drugs as Congress begins work on a five-year FDA reauthorization bill.
Currently, experts with even a slight association with the pharmaceutical industry are prohibited from serving on these panels, but the policy has proven problematic: not only are such experts barred from giving their opinions and advice to the FDA, but the drug approval process is also slowed. Committee Chairman Fred Upton (R-Mich.) said the upcoming bill should reverse “rigid, unrealistic conflict-of-interest provisions” that have delayed drug approvals.
The FDA has already begun negotiating with drugmakers and consumer advocates over the reauthorization bill. A recent hearing marked the first formal involvement from Congress.
Upton and other committee Republicans say FDA overregulation is stifling innovation and preventing drug and device companies from creating new jobs. Rep. Henry Waxman (D-Calif.) argued that while getting new products to market is important, the FDA’s mission should be protecting public health rather than fostering job creation. Energy and Commerce Democrats indicated that the safety of imported drugs will be their biggest policy focus.