Most New Drugs Rushed To Market By FDA Have Low Therapeutic Value: Study

In certain situations, federal drug regulators allow pharmaceutical companies to introduce new medications through an expedited approval program, which involves less thorough testing and studies for potential side effects. However, the findings of a new study indicate those drugs rushed to market often provide little additional benefit for patients over medications already available.

The majority of all new drugs introduced in the United States are now approved through these expedited processes, but findings published this month in the medical journal The BMJ raise serious questions about whether the therapeutic value to patients justifies the rushed approach.

Researchers from Yale University examined the benefits provided by new drugs approved by both the FDA and European Medicines Agency (EMA) between 2007 and 2017, to determine the link between the drug therapeutic ratings, or how effective and beneficial the drug will be for patients compared to other drugs already on the market, and regulatory approval through expedited programs available with both the FDA and EMA.

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Therapeutic value was measured using ratings of new drugs by one independent, non-profit organization, Prescrire, and health authorities in four countries: Canada, France, Germany, and Italy.

During the time examined, the FDA approved 320 new drugs and the EMA approved 268 new drugs. Of the FDA approved drugs, 57% qualified for an expedited program and 15% of EMA approved drugs qualified for an expedited program.

Overall, 267 of the drugs received a therapeutic value rating, with only 31% rated as having high therapeutic value by at least one organization.

Most drugs approved by both agencies failed to receive a positive therapeutic value rating. However, for the FDA, more of the drugs were approved using expedited programs, even though they did not have high therapeutic values to patients.

Only about 14% of expedited drugs approved by the FDA received a high therapeutic value rating. The rest were rated as having low therapeutic value or benefit.

In 2019, the FDA approved 60% of new drugs through at least one expedited program. Comparatively, in 2000, only 34% of drugs were approved by an expedited program. Despite the increase in expedited drugs reaching the market, the proportion of high value therapeutic drugs on the market has not increased.

Expedited drug programs are meant to allow approval for important drugs that would benefit patients, giving patients faster access. Expedited drug approvals should be reserved for drugs that are expected to provide an improvement over currently available therapies. However, neither the FDA or EMA requires data or makes approval contingent on comparative effectiveness.

Instead, most new drugs are approved on the basis of performance compared to a placebo in controlled trials or single arms studies.

“Less than a third of new drugs approved by the FDA and EMA over the past decade were rated as having high therapeutic value by at least one of five independent organizations,” wrote study authors. “Most expedited drugs approved by the FDA but not the EMA were rated as having low therapeutic value.”


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