Defective Drugs & FDA are the Target of Food & Drug Administration Act of 2007Jul 12, 2007 | Parker Waichman LLP
In the past several years, defective drugs like Vioxx, Avandia, Accutane, Zyprexa and Ketek have been found to have serious, and often, life-threatening side effects long after they received Food & Drug Administration (FDA) approval. This seemingly endless parade of defective drugs has caused many to question the credibility of the FDA itself, which is often criticized for being too close to the pharmaceutical industry. On Wednesday, the House of Representatives took steps to remedy this situation when it passed a bill aimed at improving the FDA’s drug approval system. If signed by President Bush in its current form, the Food and Drug Administration Act of 2007 (HR 2900) would usher in the biggest changes the FDA has seen in 45 years.
Though the Senate also passed its own bill (S 1082), the House version is seen as offering consumers the most protection against defective drugs. Both bills increase drug company user fees and grant the FDA more authority to monitor safety once a medicine is on the market. But the House version includes several provisions that should greatly improve the safety of approved drugs. For instance, the new legislation allows the FDA to conduct safety reviews of a drug seven years after it has been approved. Drug companies would also be required to submit their Direct-to-Consumer (DTC) advertisements to the FDA for approval, and would increase penalties for deceptive drug advertising. DTC ads would also be required to a carry a toll-free number and web address that consumers could access to report side effects.
The bill includes two other changes to the FDA drug approval process long sought by consumer advocates. The first limits so-called “Conflict of Interest” waivers on FDA drug advisory panels to one. Currently, these waivers are unlimited, and as a result, advisory panels are often riddled with pharmaceutical industry insiders. The House bill also makes FDA and industry negotiations more transparent by allowing consumer groups and the public to attend fee negotiations between the Agency and drug companies. The bill also requires that a transcript of such negotiations be published.
Finally, the House bill allows for better access to clinical trial results by the public than the Senate version. While both bills require that a clinical trails database be set up to keep the public informed about the effectiveness and risks of prescription drugs, the House version mandates that this be done within a year. The Senate version gives the FDA 2 ½ years to set up the database, and is vague as to what information would be included.
A House-Senate committee now must work out the differences between the two bills before sending the legislation to President Bush. The White House has expressed more support for the Senate version, as has the pharmaceutical industry. The pharmaceutical industry is seen as one of the Bush Administration’s most important and influential constituencies.