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FDA's New Drug Plan Finally Puts Safety First

Filed February 27th, 2008 amy

Fueled by congressional action spotlighting the agency’s oversight in 2007, the Food and Drug Administration’s new program is up for hearing at the White House today. In the wake of so many deaths due to off-label use and the massive drug recalls of recent months, many say it’s a step long overdue.

The FDA’s new “Safety First” plan intends to make drug approval less biased by making the pre-market review division and the safety office come together to make decisions. A second phase of the plan – called “Safe Use” — would allow the agency to monitor medicines after they’re approved via a database listing possible side effects with a clear schedule for follow-ups.

As anyone who has ever been in the courtroom at an Ortho Evra or Vioxx hearing has witnessed, the FDA’s stamp of approval doesn’t necessarily mean a drug is safe. Those suffering liver failure as a deadly side effect of taking antibiotic Ketek for sinus infection still question why the drug was ever approved. Families of heart surgery patients dead at the hands of Trasylol can attest that the FDA didn’t take action soon enough. Will the FDA’s new program help head off such needless loss of lives in the future? Let’s hope so.

In addition to the FDA’s negligence, off-label drug use contributes significantly to patient dangers. Doctors prescribing Fentora (a Class II narcotic only approved for treating breakthrough pain in cancer patients) for pain in non-cancer patients have contributed to the deaths of at least four people. Actiq (a similar painkiller which comes in lollipop form) has been linked to the deaths of two children and over 100 adults. Are these drugs safe if taken as prescribed? The jury’s still out.

While making the drug approval process more difficult for pharmaceutical companies is certainly an effort in the best interest of consumers, how much good will be done by the FDA’s new program won’t be seen for years. Meanwhile, ignoring the pleas of Congress, the agency is pushing ahead for the approval of its “Good Reprint Practices for the Distribution of Medical Journal Articles” guidance, which will give even more leniency to the distribution of medical and scientific information promoting off-label use to doctors. Looks like the FDA won’t be putting drug injury lawyers out of work anytime soon.

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