Alicia Mundy writes in today's Wall Street Journal:
...that there are significant hints that the new Congress that will convene in January 2009 will take aim at the structure of the FDA and try to legislate major changes that the drug industry is sure not to like--at least if two powerful players have their way.
Rep. John Dingell, D-MI, and Sen. Charles Grassley, R-IA, are the focus of this article. Both have been enthusiastically investigating the FDA's lapses and failures in both drug and food safety, calling numerous FDA officials to testify and raking many important ones such as Commissioner Andrew von Eschenbach over the coals. Just to highlight one series of exchanges, in February, news broke about deaths from tainted heparin imported from China. At first the FDA refused to request more money for overseas inspections while at the same time admitting that its inspections of the Chinese plants had been inadequate. This caused such pushback from Congress that in June, von Eschenbach and the Secretary of DHHS jointly announced that they were asking Congress for an additional $275 million for overseas inspections--but that the request was for the next fiscal year. That prompted another outpouring of fury from Congresspeople on both sides of the aisle who claimed that the money was needed right now, not later.
According to Mundy, these Congressional investigations have now created a stable of FDA whistleblowers who are busily spilling the beans on agency shortcomings, and who even have their own website. The possible FDA reforms to be sought in the next Congress include completely separating the new drug approval process from the safety review process; giving the FDA additional powers to order drug recalls and restrict advertising; and jacking up inspections and charging new drug-import registration fees.
Mundy depicts the industry as hunkering down to try to weather these assaults, with PhRMA president Billy Tauzin (the former Congressman) pretty much admitting that this is payback time for the many ways that PhRMA has misbehaved in the past.