Pittsburgh Post-Gazette
February 13, 2017
By the Editorial Board

The Trump administration has signaled support for a federal law to help terminally ill patients get access to drugs that might be their best hope but aren’t fully approved by the Food and Drug Administration. It’s a good cause.

The FDA currently allows “compassionate use” of experimental drugs in certain cases, and its statistics show that almost every time it is asked to let someone take a drug under that program, it agrees; in fiscal 2015, the applications numbered more than 1,200.

But Rep. Andy Biggs, R-Ariz., finds that program “overly complicated” and “bureaucratic.” He’s sponsoring legislation to make sure federal authorities respect (within limits) state “Right to Try” laws that say certain patients with terminal conditions can use drugs that are only partway through testing. (In Pennsylvania, the House passed a Right to Try bill in June, but it stalled and expired in the Senate.)

A statement from Mr. Biggs’ office said the proposal would make sure any bad results from these patients “are not held against” the applications for the medications’ approval.

That may be the bill’s most important feature: Under the current program, drug-regulation expert Erika Lietzan of the University of Missouri School of Law said, “companies may be cautious” about providing experimental drugs. The data from compassionate-use cases goes into the application to approve the drugs, and while the FDA realizes those patients are not part of the trials, the applicants have to account for them.

Read the full article here. 

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