FDA Plans New Board To Monitor Drug Safety

washingtonpost.com article:

"The Food and Drug Administration will create an independent board to more aggressively monitor the safety of drugs on the market as part of an effort to restore public confidence in the nation's prescription drug supply, Health and Human Services Secretary Mike Leavitt announced yesterday."

Assuming that the required knowledge can be marshaled, this initiative may prove valuable. The pharmaceutical testing done before FDA approval, to assure safety, efficacy and effectiveness, is expensive but limited. As a drug is used by millions of people for their regular care, much more experience is developed on the drug’s effects – both good and bad. Modern ICT for the first time makes it affordable to gather and analyze this information. The drug companies have little motivation to gather such information, as it may suggest that drugs be withdrawn from the market or limited in application, and it may support the legal position of patients suing for damages as a result of drug reactions. But governments can and should gather and use this information to improve protection of their citizens. Not surprisingly, the approval of this new function for the FDA is likely to be the subject of intense political controversy.