The FDA has 10 months to approve or deny a drugmakers’ application for most drugs. Drugs that treat conditions that have few treatments typically get priority review, giving the agency six months to make a decision.
But from mid-October to mid-November, the FDA approved five drugs in just eight weeks, according to Bloomberg.
Breakthroughs in biotechnology and genetics have allowed drugmakers to submit highly detailed data to federal regulators. Companies are also communicating earlier and more frequently with the FDA, which can help to avoid issues in the preliminary stages of drug approval and allow drugs to be approved on the first try.
The fast pace of approvals allows patients with rare or untreatable diseases to get access to potentially lifesaving drugs much faster. But patient safety advocates say their concerned the fast approvals could lead to drugs that are less safe.
Studies have shown that drugs approved on a faster timeline are more likely to have safety problems after they enter the market, according to Bloomberg. They are also more likely to offer fewer benefits than expected.
As an example, AMAG Pharmaceuticals’ drug, Makena, was approved to delay preterm births. Public Citizen, a consumer advocacy group, has been lobbying the FDA to remove the drug from the market after data released years after the drug was approved showed that it may not be effective. On Oct. 30, an FDA panel recommended that the agency take the drug off the market.
A study cited by Bloomberg said that drugs that get an expedited approval are 48 percent more likely than to get an update to their warning labels or contraindications that restrict their use. The study also tied faster drug approvals to increased boxed warnings,the most severe type, as well as more market withdrawals.
But Aaron Kesselheim, MD, a professor at Harvard Medical School, told Bloomberg the increased risk is “reasonable, if that drug is a very promising drug that meets an unmet medical need for a serious or life-threatening condition.”
Janet Woodcock, MD, director of the FDA Center for Drug Evaluation and Research, told Bloomberg that finding flaws in a drug after it is on the market could be a positive thing because “otherwise, we aren’t taking any chances; we are still making them wait too long to get their hands on this therapy that will extend their lives.”
Read the full article here.
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