Healthy Skepticism Library item: 918

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Wilde MATHEWS.
FDA Issues Drug-Safety Guidelines Withdrawals From Market Of Approved Medicines Add to Pressure on Agency
THE WALL STREET JOURNAL 2005 Mar 25

Full text:

Federal regulators issued new guidelines laying out when, and how, drug makers should go beyond label warnings and incorporate other restrictions on the use of a drug.

The document, which came with two related regulatory guidances on how pharmaceutical companies should detect safety issues during clinical trials and after medicines are on the market, comes as the Food and Drug Administration is seeking to shore up its emphasis on safety. The agency is under congressional scrutiny in the wake of high-profile drug withdrawals and as its acting commissioner, Lester Crawford, is seeking Senate confirmation.

The goal is “closer and earlier discussions and collaboration between FDA and industry on safety issues,” said Paul Seligman, director of the agency’s office of pharmacoepidemiology and statistical science.

Still, the new guidelines aren’t likely to dispel all concerns raised by members of Congress. For one thing, the guidelines say that if a drug maker feels it needs a risk-minimization plan for a drug with known side effects, it should go first to the FDA division that reviewed the drug for approval, which will work with other parts of the agency such as the drug-safety office. This is the current practice, but some lawmakers have argued that safety matters should be handled more independently. The FDA also plans to create a new drug-safety board that is supposed to add a new layer of outside review.

The agency’s approach is a sensitive topic, because doctors, pharmacists and drug companies have all raised questions about the FDA’s authority to impose limits on how medicines are prescribed and promoted. At the same time, the regulators have come under pressure to impose more limits on drugs with known side effects. The agency tends to work out such agreements as conditions of a drug’s approval. Once a drug is on the market, the agency is less able to demand restrictions.

In the new guidelines, which in many cases codify practices already in place, the FDA takes a cautious line. The agency says that while it hopes that drug companies will determine when special measures are needed, it “may recommend” a plan “based on the agency’s own interpretation of risk information.” It intends to bring questions about risk programs to public meetings of its advisory committees, which are made up of outside experts.

The agency’s examples of types of drugs likely to require special risk measures include those that cause birth defects and powerful addictive painkillers. More broadly, the FDA says that some drugs may need restrictions because “safe and effective use call for specialized health-care skills, training, or facilities to manage” the side effects.

The agency doesn’t officially have the power to regulate the practice of medicine. But it lists measures that drug makers might consider for very risky drugs, such as limiting distribution to certain pharmacies, allowing prescriptions only by specially certified doctors, or dispensing drugs only to patients with certain lab-test results. Some drugs already have such restrictions, such as the powerful acne medicine Accutane, which causes birth defects when taken by pregnant women.