FDA bill could improve drug safety monitoring

The U.S. Senate passed a bill on May 9 that would expand the authority of the Food and Drug Administration to ensure drug safety:

The bill calls for a fundamental change in the philosophy and operations of the drug agency, requiring it to focus on the entire life cycle of a drug -- not just the years before its approval -- as well as the experience of patients who later take it.

Under the bill, the government would establish a surveillance system to track the adverse effects of prescription drugs. Scientists would analyze data on tens of millions of patients, looking for signals that particular drugs pose serious risks.

... Under the Senate bill, the government could order changes in a label and require the manufacturer to conduct more studies and clinical trials of a drug already on the market.

This is good news. Because psoriasis is a lifelong disease, psoriasis patients may need treatment for decades--far longer than drug testing could possibly cover before a product is approved for use. We have been advocating for the longterm monitoring of approved psoriasis treatments, and this bill may advance that goal.

The bill would also encourage testing of more treatments in children:

The bill would give financial incentives to drug companies to study the effects of their products in children. The reward would be scaled back for drugs that already had sales of more than $1 billion a year in the United States.

Experts estimate that two-thirds of the drugs prescribed for children have not been studied or labeled for pediatric use.

As was discussed in our podcast on psoriasis in children, there are few studies of how psoriasis treatments fare among pediatric patients.

A version of this bill is expected to be signed into law later this year.