Will FDA Update How It Approves Drugs After Alzheimer’s Mess?

Will FDA Update How It Approves Drugs After Alzheimer’s Mess?

May 14th, 2022 // 7:56 pm @

Almost a year after FDA approved a controversial medicine to help Alzheimer’s disease, legislators are trying to amend the FDA drug approval process. The outcome of those efforts could have a significant impact on pharmaceutical companies in future years.

The House Committee on Energy and Commerce is charged with oversight of US drug safety and biomedical research. It stated this month that it intends to give FDA more say over accelerated NDAs if the pharma company doesn’t do follow-up clinical studies after the approval and release of the drug.

The new provision is part of the agency’s funding reauthorization and will probably pass this fall. It comes after FDA approved aducanumab, an antibody medicine that may reduce plaque accumulation in the brain related to Alzheimer’s disease.

Although a panel of drug experts and medical professionals voted against approving the drug, but FDA gave it fast-track status. Three independent panel members protested the fast-track approval by resigning. The approval is still being reviewed in several federal investigations. The drug was developed by Biogen.

Aducanumab is only one reason the drug approval method is being criticized. Since the fast-track program was started, it has approved 279 drugs and 2/3 were in the last 10 years.

Pharmaceutical companies are highly motivated to get fast-track approvals, but some industry experts say the original intent of the law is being missed. The president of the National Cancer For Health Research, Diana Zuckerman, stated this month that fast-track approval began as a relatively rare program for a few drugs. But today, most new cancer medicines are using the fast-track or expedited approval method.

Plus, pharmaceutical companies are sometimes slow to generate the follow-up clinical studies that they must provide after approval. FDA lacks significant power to make them provide this information. However, pharmaceutical companies should be aware that the proposal before the House of Representatives and the Senate could give the agency more authority in this area.

FDA Commissioner Robert Califf has pledged this year to reform the accelerated approval process. Clinical researchers in the industry who spoke to the press this month said reforms should happen soon, and the proposed bill is a step in the right direction. They added there should be additional FDA oversight and additional changes that drug companies should know about that could make it more difficult to fast track drugs.

The desire to change the fast-track process is seen in recent data. A study in 2021 determined that 13% of medicines that received accelerated approval from 1992 to 2015 were not converted to a full drug approval within five years. They stayed on the American market for almost 10 years without enough clinical trial data to do the conversion.

FDA gave Biogen 9 years to finish its clinical trials on aducanumab, which some say is far too long. Biogen said it would do the trials in less than four years. A Biogen representative counters that data from that trial has showed clinical decline in Alzheimer’s patients slowed for those taking the medication.

However, post-market clinical trials can take years, especially for diseases that progress slowly. It’s also tough to find clinical trial participants because people want to get a drug that will help and not a placebo. If a drug isn’t converted to a full approval within a reasonable time, FDA usually just asks the company pull it from the market. FDA doesn’t have a lot of power after a drug gains approval.

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