New FDA Reforms: Could They Prevent Another "Fen-Phen"?

Washington, DCThe new FDA report: The Future of Drug Safety -- Promoting and Protecting the Health of the Public, outlines significant reform of the drug-approval process and a new "sentinal" system to expedite the recall process. Could these changes prevent other health crises like the one that led to the recall of Fen-Phen?

Fen-Phen: An "Unacceptable Risk"
After reports of valvular heart disease and pulmonary hypertension among users of Fen-Phen, the FDA requested its withdrawal from the market in September 1997. Dr. Michael A. Friedman, Lead Deputy Commissioner of the FDA, stated at the time that fen-phen posed: "an unacceptable risk ... to patients."

The FDA has received reports of 123 deaths in which Fen-Phen was identified, and continues to regularly receive reports of heart valve disease linked to Fen-Phen. As American Lawyer magazine reports, more than 50,000 product liability lawsuits have now been filed against the drug company Wyeth regarding Fen-Phen.

This has lead some critics to wonder: with so many patients having problems with Fen-Phen, why did it take too long for the government to get the message and recall the product? Would better communication between physicians and the government have sped the recall and potentially saved lives?

Fen-Phen: A "Wake-up Call"
One of the biggest impacts from the 1997 Fen-Phen disaster was a call for more oversight and improvement of the "safety" of drugs on the market and those awaiting regulatory approval.
"What happened with drugs like Fen-Phen and Vioxx... these were a wake-up call to the FDA," said Dr. David Brown of St. Louis, MO.

Most guidelines for improving drug safety involve the tightening up of the FDA's scientific regulatory review process and improving its communications with physicians, patients and other government agencies.

"It's taken 10 years for [the reforms] to happen, but that's pretty fast in 'government years,'" says Dr. Brown.

New FDA Technology
The FDA is making a number of technology upgrades, starting with its Adverse Events Reporting System database, a web-accessible computer system. The system is going through a major overhaul, to enable FDA safety reviewers to more efficiently and effectively analyze "adverse event reports" submitted to the FDA by physicians.
As part of another initiative, in early March the FDA sponsored a public meeting to explore opportunities for linking private- and public-sector safety monitoring systems for a nationwide medical product safety network. This "sentinel" system is designed to gather information about potential drug risks and expedite this information to doctors across the country.

These changes are an effort to leverage new technologies to build bridges between doctors, patients and regulators. As the FDA writes in its report: "The U.S. drug safety system is on the verge of major transformations driven by the rapid evolution of science, technology, and the healthcare system."

Fen-Phen: What's Next?
Meanwhile, new problems have emerged for former users of Fen-Phen.

The New England Journal of Medicine now reports that users of Fen-Phen diet pills are more than twice as likely to develop PPH, a fatal lung disorder, than other patients. With an estimated 5-7 million previous users of Fen-Phen related products, the number of reported cases of PPH may be on the rise.

Since the Fen-Phen recall, the Mayo Clinic has reported retrospective findings on the subset of their patient population who had dietary drug exposure. The study found a 33% incidence of significant valvular disease, according to the previously defined criteria.

Patients who believe they have developed PPH as a result of taking diet pills such as Fen-Phen, Redux, or Pondimin may be entitled to take legal action. Although it's now been 10 years since the recall, it seems like the Fen-Phen saga is far from over.