Seniors suffer the most from antiquated FDA approval process

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Americans have been heartbroken as report after report shines a light on the COVID-19 pandemic sweeping through nursing homes and decimating some senior community populations. Not only have our seniors been struck in their final years with a hideous virus, but they are also the victims of an antiquated drug approval process that is nearly six decades old and in need of drastic improvement.

The fact is, we already have a model that works, which can be adapted for use in America with minor changes.

While some streamlining of the FDA approval process has taken place, especially in the midst of the HIV/AIDS epidemic, it is still denying our seniors, their families and physicians the opportunity to make informed choices about the level of risk they are willing to take (advised by their doctors) with promising but not officially approved treatments, pharmaceuticals and therapies. Let seniors, and anyone dealing with a serious medical condition, have the opportunity to make informed decisions.

The biopharmaceutical industry has also seen major changes since 1962, when Congress passed foundational legislation to ensure that consumers would not be the victims of unsafe and ineffective medications. The advent of biotechnology, gene therapy, artificial intelligence, and the internet contributed to improved treatment results for patients and longer life spans. Meanwhile, the FDA has made only incremental improvements (with exceptions) to the rules which shorten the review time required for a drug to receive FDA approval, including Priority Review, Accelerated Approval, Fast Track and Breakthrough Therapy Designation.

These programs reflect the difficulty the FDA and Congress have in balancing the need to protect the American people against the need to make new vaccines and treatments available to those who need them, especially when dealing with life and death and serious illnesses such as the novel coronavirus.

We do not need to reinvent the wheel; We just need to expand an existing program.

In 2014 the Japanese Health Ministry established an accelerated conditional approval pathway for regenerative medicines that enables more patients to access products like tissue grafts and stem cell therapies that have demonstrated initial safety and efficacy, but have not completed the many years of standard clinical testing required under the country’s formal approval process. This program, which is especially beneficial to Japanese seniors, actually builds upon the Parallel Track approval process that was initiated by the FDA in 1992 to allow AIDS/HIV drugs to be accessible immediately following successful safety testing, but before completion of the more rigorous and time-consuming efficacy trials. On Oct. 5, 1992 the first drug to be approved under Parallel Track, stavudine, became available, extending the lives of thousands of sick people before eventually receiving standard FDA approval.

By expanding Parallel Track, all drugs that treat serious and life-threatening illnesses would be conditionally approved once early stage clinical trials suggest that a medicine has a safety profile consistent with the severity of the disease being treated and a likelihood of patient benefit. All physicians would then be able to prescribe such treatments to fully informed patients. As part of the program, the product developer would be required to collect relevant data and results from patient use. In addition, a public database would be established where physicians prescribing Parallel Track approved therapies would be required to post anonymized treatment results.

The public database would enable doctors, patients, and the public health community to quickly learn about the successes, failures, benefits, and side effects that patients using Parallel Track approved treatments are experiencing. The FDA already collects real-world data on the side effects associated with approved medicines, which it uses to monitor safety and keep labels updated. Expanding this program would result in additional “real time” comprehensive patient data.

Now is the time for the United States to take this bold step forward and create an accelerated approval pathway for developmental treatments that give patients and doctors greater control over their health care. Expanding Parallel Track to include a publicly available database of real-world treatment results would accelerate biopharmaceutical innovation, reduce development costs and lower drug prices while expediting new standards of care and cures.

Seniors can’t wait 10-12 years to have a drug approved, nor can they pay for drugs that are priced to quickly recoup the $2.6 billion dollars it costs to gain approval. With the expansion of Parallel Track, more seniors will be able to walk out of hospitals and live longer healthier lives.

Diane Abbitt is a Los Angeles attorney who played a leading role in the 1990s campaign to secure early access to not-yet-FDA-approved drugs to treat AIDS. Bartley J. Madden is an independent researcher in Florida. Japan’s conditional approval pathway was based on a proposal in his book, “Free to Choose Medicine: Better Drugs Sooner at Lower Cost.”

Tags Accelerated approval Breakthrough therapy Clinical trial Coronavirus COVID-19 Fast track FDA Food and Drug Administration Medication Pharmaceuticals policy Pharmacy priority review

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