On Prescription Drugs, Patients Must Be 'Free to Choose'

Examiner (Washington, D.C.), The, August 23, 2017 | Go to article overview

On Prescription Drugs, Patients Must Be 'Free to Choose'


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. …

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