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Spangenberg Shibley & Liber, LLP | Jun 10, 2012

FDA Fast-Track: Road to Patient Wellness or Slip Toward Disaster?

Categories: Articles

The FDA has a special designation for drugs it believes would significantly improve patient outcomes if readily available. The fast-track process helps facilitate the development and quick review of drugs that treat an otherwise incurable condition, like AIDS or cancer, or provide a much better prognosis or quality of life than drugs already on the market, including the absence of severe side effects.

Manufacturers of fast-track drugs work closely with the FDA throughout the process. More frequent communication between the FDA and a drug company helps make the development and review process more efficient and provides much needed treatments to patients more quickly.

There are some drawbacks to the fast-track process, however. Although carefully monitored by the FDA during development and review, fast-track drugs are not required to go through the clinical trial phase, as the majority of drugs are. The clinical trial process is important because it reveals potentially dangerous drug side effects or other issues with the drug not identified in the development and review process.

The FDA also has a history of failing to address concerns with fast-track treatments once they hit the market. For example, this spring, the Government Accountability Office looked into the FDA's fast-track program, and found that its recall process is alarmingly deficient. The FDA does not track the reasons specific medical devices fail, nor does it have a history of following up on the recall process. This means that many devices that have been deemed unsafe and recalled may still be in use.

Recent examples of fast-tracked drugs include Regorafenib and another known as AV7909. Regorafenib, produced by Bayer, treats metastatic stromal tumors in the gastrointestinal tract. It received fast-track status to provide an option to patients for whom the currently available drugs have not worked. AV7909 is an anthrax vaccine in development by NuThrax. The vaccine uses already available BioThrax and combines it with a new compound in the hopes of creating a new anthrax vaccine.

Although the FDA is charged with regulating drugs and other medical devices to ensure they are safe for public use, approval does not necessarily guarantee that a drug or device is entirely so. The fast-track process streamlines or skips important steps in the drug approval process, which puts more of a burden on manufacturers to ensure safety.

If you or a loved one has been harmed or killed by a dangerous drug, contact an experienced pharmaceutical products liability attorney.