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Cure for cancer would become more likely if FDA streamlined the drug approval process

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The Biden Cancer Initiative recently hosted a meeting in Washington, D.C., pursuant to former vice president Joe Biden’s campaign to create a better cancer research and care system. As the conference came to a close, I marked the 10th anniversary of my youngest brother’s death from cancer, which came only the month after his first grandchild was born.

Biden’s fight is certainly our fight. However, to win we need to focus not only on innovative research but also on the institutional problems of the Food and Drug Administration (FDA). Along with our president at The Heartland Institute and former Rep. Tim Huelskamp (R-Ky.), we have undertaken a major project to reform the current twentieth century-era FDA system that slows delivery and adds to the costs of the treatments cancer sufferers desperately require. We welcome the chance to work together with Biden to create an innovative drug approval process more responsive to patient needs.

{mosads}At the D.C. meeting, Airbnb committed to providing more rooms for individuals during their cancer treatments. Lyft stated that it will deliver more rides for patients to and from treatments. And WeWork announced that it will provide hubs where researchers and patients can meet.

These praiseworthy pledges come from entrepreneurial companies that are revolutionizing lodging, transportation, and business accommodations. How can we best unleash such entrepreneurial efforts to cure cancer?

In the past, Biden promoted the “Beau Biden Cancer Moonshot,” named after his late son. In response, Congress authorized $1.8 billion over seven years for this cause.

However, we believe that a cure for cancer would become more likely if the FDA streamlined the drug approval process. A Tufts University study found that on average it takes over a decade to bring new drugs of any sort from research lab to patients, and at a cost of nearly $2.6 billion.

Much of that time and cost results from FDA testing and certification requirements. The $1.8 billion doesn’t quite cover one average drug. Many of the most innovative companies abandon development of promising treatments because these costs are too prohibitive.

Funding is crucial to finding cures for cancer and most other ailments, and the private sector has taken the lead. In 1974, industry provided only $48 million or 2 percent of cancer research funding. By 1997, it provided $1.6 billion or 31 percent. Since then, private investments have continued to grow. Large pharmaceutical companies have increased investments in cancer-therapeutics startups, from $2 billion in 2013 to $4.5 billion in 2017.

The FDA, however, poses a problem. After a new drug passes Phase I safety tests, it can be delayed for a decade or more in Phase II and III tests to determine efficacy, which doses work best on which patients, and the like. We all want safe drugs not only to be as efficacious as possible but also to be available in time to prevent suffering and save lives.

We are promoting an innovative certification policy that can expedite testing and approval: Free To Choose Medicine (FTCM). Once a promising drug passes Phase I safety trials and at least one Phase II efficacy trial, a manufacturer would be able to opt to sell the drug at market prices on a dual, dynamic FTCM track. Patients, in consultation with their physicians, could then either access these promising FTCM medications or continue to wait for drugs still languishing for years in the traditional FDA process.

Smaller, entrepreneurial drug companies would be able to offer their best, safest products for testing by patients in the market, and have more opportunities to invest in promising research, knowing there is a less-costly track for testing and approval.

Biden rightly said, “The more data we have, the more opportunities we’ll have to unlock the secrets of cancer.” The characteristics and medical history of patients using medications on the FTCM track, as well as the results of the medication would be entered into a trade off evaluation drug database, with patient privacy protected. Researchers, physicians, and patients would have access to this data, which would highlight the effectiveness of medications.

FTCM is not some fringe policy. For the last three years, Japan has been implementing a FTCM system for its regenerative therapies. With the oldest average population and the longest life expectancy of any country, Japan needs to get innovative medications to its citizens as quickly as possible.

Cancer is a disease that harms all Americans regardless of political party or ideology. The Heartland Institute welcomes the opportunity to work with Biden and all others to reform the current approval system so that treatments and even cures will come more quickly, and so that individuals like his son and my brother in the future might live.

Edward Hudgins is research director at the Heartland Institute and expert on regulatory and science policy. He has previously worked at the Heritage Foundation, Cato Institute, Atlas Society and Joint Economic Committee of Congress.

Tags Cancer research Cancer treatments FDA Joe Biden Tim Huelskamp

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