Pennsylvania Bill Would Expand Right to Try, Further Reject Some FDA Restrictions

HARRISBURG, Pa. (Sept. 26, 2018) – A bill introduced in the Pennsylvania House would expand the states “Right to Try” law and would set the foundation to further nullify in practice some Food and Drug Administration (FDA) rules that deny access to experimental treatments by terminally and chronically ill patients.

A bipartisan coalition of 19 sponsors introduced House Bill 2633 (HB2633) on Sept. 11. The legislation would expand the state’s Right to Try law to allow terminally or chronically ill patients to use investigational stem cell treatments that haven’t received final FDA approval.

Pennsylvania passed its Right to Try Act in 2017. At the time, the Federal Food, Drug, and Cosmetic Act prohibited general access to experimental drugs. However, under the expanded access provision of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360bbb, patients with serious or immediately life-threatening diseases could access experimental drugs after receiving express FDA approval.

The Pennsylvania Right to Try Act bypassed the FDA expanded access program and allowed patients to obtain experimental drugs from manufacturers without first obtaining FDA approval. This procedure directly conflicted with the federal expanded access program and set the stage to nullify it in practice.

After 40 states had enacted similar laws, Congress finally jumped on the bandwagon and passed a national Right to Try Act in May 2018. Passage of the federal bill was the direct result of action that started in the states five years ago.

But passage of a national Right to Try law isn’t the end of the road. While the federal law opens up the process for terminally ill patients to access experimental treatments, the FDA still blocks chronically ill patients from using them. It also limits the types of treatments and technologies covered. Now states are looking for ways to expand the concept despite FDA rules.

In 2016, Texas considered a proposal to expand its Right to Try law to cover all chronically ill patients. Last year, Louisiana enacted a law expanding Right to Try to include robotic technology that assists patients suffering from terminal degenerative muscular diseases with mobility. Passage of HB2633 in Pennsylvania would take another step forward and further nullify intrusive FDA regulations that come between a doctor and a patient.

Although Right to Try only addresses one small aspect of FDA regulation, it provides a clear model that demonstrates how to nullify federal statutes that violate the Constitution. The strategy narrows the influence of nullification to limited aspects of the law itself, which has proven to be very effective.

The impact of Right to Try isn’t merely theoretical.

Since the Texas Right to Try law went into effect in June 2015, at least 78 patients in the Lone Star State have received an experimental cancer treatment not allowed by the FDA. While the FDA would have allowed these patients to die, Houston-based oncologist Dr. Ebrahim Delpassand continued their treatment through the Texas law. (Watch a video about Dr. Delpassand here.)

The experience with Right to Try shows how state efforts can not only effectively nullify overreaching federal actions, it can also drive change in Washington D.C. The shift in federal policy was a direct result of pressure caused by 40 states effectively ignoring the FDA. It also shows how small steps lead to bigger steps. Now that Right to Try has been firmly established, we’re seeing states like Pennsylvania and Louisiana looking to build on the success.

WHAT’S NEXT

HB2633 was referred to the House Health Committee where it must pass by a majority vote before moving forward in the legislative process.

 

 

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