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The House needs to help patients from being victimized by antiquated technology


Currently Right-to-Try laws have been passed in 38 states and last year in the US Senate. The Right-to-Try is a “right” that would be extended to terminally ill Americans permitting them access to experimental medications unencumbered by various FDA regulations that currently place high hurdles in front of patients attempting to access these treatments.

Despite prudent efforts by Food and Drug Administration (FDA) Commissioner Scott Gottlieb to tweak the Agency’s expanded access and compassionate use programs, the FDA has traditionally viewed expanded access as being successful.

{mosads}According to a recent GAO report, the FDA was cited as granting nearly 99 percent of approximately 5,600 requests for expanded access from 2012 to 2015. In France in 2007, a country with 20 percent of the population of the United States, 20,000 citizens were granted compassionate use versus the 5600 over a 4 year period in the United States..


This makes this “right” a necessity for terminally ill Americans or as I like to call them warriors. Our friend ALS warrior, Frank Mongiello has said, “I’m going to die, I don’t need the FDA or anyone else protect me from that.”

For many like Frank, death is a certainty and despite that, he and many others valiantly agree to try any treatment that could help them — or even more selfless, potentially help advance the understanding of a treatment that could help others down the road.

The Right-to-Try was a labor of love by Sen. Ron Johnson (R-Wisc.) who fought valiantly to get his version of the Right to Try (S. 204), the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017” passed in the U.S. Senate with unanimous consent.

This means that all 100 U.S. senators agreed that his bill was a good thing and that the White House, via the efforts of Vice President Mike Pence supports. It should be noted that as the Governor of Indiana, the vice president proudly signed the Indiana Right to Try into law.

Instead of recognizing the unanimous support garnered by the Senate bill and voting on it, the House Energy and Commerce (E&C) Committee held a hearing in October of 2017 regarding the Legislation.

The Committee held this hearing despite having two House versions of a Right to Try bill sitting idle in the House all year. Clearly those bills didn’t pass the Committees muster otherwise, wouldn’t they have held a hearing sooner?

So why hold a hearing on the Senate bill that had bi-partisan support and passed the Senate unanimously?

At the hearing, FDA Commissioner Scott Gottlieb testified and acknowledged that the perception of FDA’s expanded access program isn’t perfect. He also told the committee of a few changes the agency is working to address and that one of the primary reasons patients cannot obtain these investigational medicines is that a company lacks supply of the treatment.

Gottlieb also recommended narrowing the eligibility of the bill from patients who face a “life-threatening disease or condition” to those facing “terminal illness.”

Sounds like easy changes to make, yet we still have seen no action in the Committee or the House. House E&C Chairman Greg Walden (R-Ore.) himself faced the challenges of the FDA process when dealing with and recovering from the Swine Flu nearly a decade ago.,

At the time, Congressman Walden asked Health and Human Services Secretary Kathleen Sebelius, “Why are you still using an antiquated technology to produce flu vaccine?” That is the same question terminally ill Americans have been asking about the speed and process for approving treatments for them, which takes up to 15 years and several billion dollars — hence the need for a Right-to-Try.

Many view the drug maker’s tendency to drag their feet, like Congress at times, for a usual reason — money. The flu vaccine isn’t a high-profit item and neither are terminally ill diseases which affect small segments of the population. It makes more sense to invest in new drugs to cure erectile dysfunction.

But money and profit margins often serves as a red herring at times. The true issue is the removal of the ability to make the best and well-informed choices by patients and their doctors, of making patients subjects rather than participants in their medical care, while empowering the Washington beltway.

The FDA has remarkable half century history in protecting the nation’s food and drug supply from adulteration, harm and hazard, but it was never meant to substitute for a patient’s pharmacist or doctor.

At the hearing, Chairman Walden of the House Committee on Energy and Commerce said, “If the goal is to help terminal patients — the more conditions we sweep in, the more we risk undermining the whole venture to be tailored to those who don’t have good options.”

He also told Gottlieb that his Senate counterparts have said if the bill is altered, it will fail.

The House of Representatives should stop their delay — the case is made for the Right-to-Try, a subject which has now been subject to debate for several years. The House should vote on and pass the Senate version of the Right to Try (S.204) now so Americans no longer have to be victimized by antiquated technology, profit margins or whatever excuse the system creates.

Donald J. Mihalek is the executive vice president of the Federal Law Enforcement Officers Association Foundation and Michael Smith, vice president of Gastroparesis Patient Association for Cures and Treatments.

Tags Expanded access Flu pandemic in the United States Food and Drug Administration Greg Walden Health Influenza vaccine Kathleen Sebelius Mike Pence Pharmaceutical industry Right-to-try law Ron Johnson Scott Gottlieb

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