FDA Issues Guidelines for Pharmaceutical Companies on Prescription Drug Label Warnings, Other Safety Issues

FDA on Thursday issued new guidelines detailing "when and how drug makers should go beyond label warnings and incorporate other restrictions on the use of a drug," the Wall Street Journal reports. The guidelines were issued along with two related guidances on how drug companies should monitor safety issues during clinical trials and after drugs reach the market.

According to the Journal, many of the new guidelines "codify practices already in place" and show that FDA is taking "a cautious line" in approaching the "sensitive topic" of limiting prescriptions and marketing. FDA noted that drugs that will probably require special risk measures include those that are known to cause birth defects and addictive painkillers. FDA stated that some drugs could need restrictions because "safe and effective use call for specialized health care skills, training or facilities to manage" the side effects.

The guidelines also reinforce the agency's current practice of reviewing a risk-minimization plan brought by a drug maker. According to the guidelines, the plan first would be reviewed by the FDA office that initially studied the drug for approval and then that office would work with other divisions in the agency, such as the drug safety office. Some lawmakers have said such reviews should be handled by an independent safety board instead of FDA, which is "under congressional scrutiny in the wake of high-profile drug withdrawals," the Journal reports.

FDA says it hopes pharmaceutical companies will determine when special restrictions are needed, but the agency stated it might recommend a plan "based on the agency's own interpretation of risk information." FDA said it intends to make public its concerns about companies' risk programs during advisory panel hearings.

FDA does not officially have the power to "regulate the practice of medicine," and doctors, pharmacists and drug makers "have all raised questions about the FDA's authority to impose limits on how medicines are prescribed and promoted," the Journal reports. The guidelines include measures that drug makers could consider for drugs with known side effects, such as limiting distribution to certain pharmacies, allowing prescriptions only by doctors with specific certifications or giving drugs only to patients with certain lab-test results.

Paul Seligman, director of FDA's office of pharmacoepidemiology and statistical science, said the aim of the guidelines is "closer and earlier discussions and collaboration between FDA and industry on safety issues" (Wilde Mathews, Wall Street Journal, 3/25).