If it becomes law, the Senate bill, called the Food and Drug Administration Revitalization Act, could shift the balance of power between regulators and the pharmaceutical industry. It requires the FDA to monitor drugs after they go on the market and provides new funding for that job. The bill would also require companies to make public the results from many of their studies.Click here to access the article (subscription required).
The measure would grant the FDA authority to take major actions, including requiring new studies, limiting distribution or ordering label changes if the agency thought they were necessary. Currently, the FDA's authority in that area isn't clearly delineated, so the agency often has to negotiate with companies, using its leverage before it grants approval for a new drug or the indirect threat of its bully-pulpit power to get the concessions it seeks.
Thursday, May 10, 2007
More power to the FDA?
If the bill reauthorizing FDA user fees passes Congress, as expected, then it most likely will bring "sidecar" regulations for Pharma. From the Wall Street Journal: