There must have been quite a party in Rockville (Md., at FDA headquarters) last Thursday evening. Earlier that day, the U.S. Senate approved the FDA Amendments Act (FDAAA) of 2007 "without debate," and news organizations were quick to enumerate the new powers the Act would bring to the Agency. According to the
Baltimore Sun, the Act gives FDA new authority to:
- Order warnings on drug labels
- Review drug ads before they air on television
- Make results of drug clinical trials available publicly
- Reduce the number of expert advisers with industry ties
- Require studies of new drugs' performance
- Probe patient databases for early signs of side effects
FDA Commissioner Andrew von Eschenbach
issued a statement on Friday (Sept. 21) thanking Congress for passing the legislation, especially the sections that reauthorized the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and Modernization Act (MDUFMA). Given how difficult it is for domestic programs to come by federal funding these days, the Commissioner and other FDA officials will undoubtedly welcome the "clink" of industry's coins in the coffer.
The
Sun's reporter noted that the FDAAA is "expected to be signed into law by President Bush," and with all of the hullabaloo over drug safety that has come down the pike in the last three years, one would think Mr. Bush would feel a sense of urgency about signing off on the bill. But perhaps more pressing issues have come before him, such as welcoming the 2006 and 2007 NCAA sports champions to the White House last Friday, or delivering his weekly radio address on Saturday. This week certainly has been hectic for the President; yesterday he met with President Abbas of the Palestinian Authority and President Lula of Brazil, and today he addressed the United Nations General Assembly and met with Iraqi Prime Minister Maliki.
So, it looks like the really big party -- the one they can throw at the Agency when President Bush finally signs the bill into law -- will have to wait a few more days. It feels rather anticlimactic, doesn't it? Since "Vioxx" became a household word and a symbol for all that critics think is "wrong with" both the pharmaceutical industry and FDA, the Agency has been hounded to police drug and device companies more closely. But how much could FDA do without sufficient regulatory muscle? Now, there's a light up ahead, but it's not shining on Rockville. Yes, "all the world's a stage," and Agency staff are "merely players," but isn't it time to give them their "star turn" and see what they make of it?
-HP
