From Martin Shkreli to EpiPen, the outrageous costs of prescription drugs have fueled short-lived media storms with little reform to show for. The Food & Drug Administration's inefficient drug approval process is undoubtedly a root of the problem. It can easily take 12 years and cost a pharmaceutical company $2 billion to pass the FDA's clinical trials and bring a drug to market. Meanwhile, patients dealing with serious or life-threatening illnesses have little access to potentially life-changing or life-saving drugs undergoing the approval process, extinguishing what little hope they had left.
One bold idea could easily change that, providing patients of all kinds with faster access to the drugs they need: Free to Choose Medicine.
Named after Milton Friedman's famous phrase, FTCM is a proposal by the health care researcher Bartley Madden to create a new track in the FDA's approval process. Madden explained the proposal with former Office of Information and Regulatory Affairs head Susan Dudley in The Hill:
First, a free to choose track would complement FDA's existing clinical trial track. This would enable patients, advised by their doctors, to contract with a drug developer to use not-yet-approved drugs after Phase I safety trials are successfully completed and one or more Phase II trials have demonstrated continued safety and initial efficacy.
Free-to-choose drugs could be available seven years earlier than the status quo and fundamentally change the economics of drug developmental costs and drug pricing — to the benefit of patients. In this new, fast-paced, competitive environment, many existing drugs, over time, would face heightened competition thereby forcing prices down. A premium would be placed on scientific skill in developing breakthrough medicines, not skill in dealing with the FDA bureaucracy.
A similar policy proposal dubbed "Right to Try" has been passed in 37 states, allowing patients to request access for not-yet-approved drugs from pharmaceutical companies. A national FTCM law, however, could be more preferable than the current swiss cheese approach of Right to Try in the states that is missing important incentives included in FTCM.
After all, pharmaceutical companies, fearing that the FDA could use adverse side effects incurred by Right To Try patients to put the brakes on their clinical trials, have little incentive as of now to give patients access to potentially-lifesaving drugs. Moreover, insurance companies are unwilling to cover the costs of these experimental drugs for similar reasons.
Congress has the authority to clear these legally-murky waters with a national FTCM law, giving new hope to patients across the country. Moreover, such a law could drastically lower the costs of pharmaceuticals for millions of Americans with the right incentives in place.
Earlier this month, the Senate passed a national Right to Try bill. While the proposal is certainly a step in the right direction, it faces an uphill battle in the House and lacks key incentives for Big Pharma to embrace patient choice.
Madden's proposal, on the other hand, includes a new track for pharmaceutical companies that participate in FTCM, allowing faster approval for drugs that have been proven to work on patients who volunteer to try them. This new track could drastically speed up the time it takes to bring new drugs to market, saving companies and consumers billions of dollars.
With Obamacare reform out of the national limelight, for now, Congress should be looking for bold new ideas to make healthcare more affordable. Free to Choose Medicine is one such exciting idea that is already shown to have popular support, as evidenced by the proliferation of Right to Try in the states.
Casey Given (@CaseyJGiven) is a contributor to the Washington Examiner's Beltway Confidential blog. He is the executive director of Young Voices.
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