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ANH ACTION ALERT: FDA Tries to Run Out Clock on Bill to Help Dying Patients

Posted By Gretchen DuBeau - ANH-USA, Friday, October 7, 2016
Updated: Wednesday, October 5, 2016

New federal legislation offers dying patients new hope. It needs our support. Action Alert!

The legislation, introduced by Sen. Ron Johnson (R-WI), would prohibit the federal government, particularly the US Food and Drug Administration, from blocking patient access to experimental medications.

FDA Commissioner Robert Califf was scheduled to attend a hearing on the bill, but canceled at the last minute.

As the law stands now, FDA bureaucrats can continue to throw numerous roadblocks and hurdles into the path of patients who desire access to experimental and potentially life-saving drugs, as they have been doing for quite some time.

Here’s how it works—or rather, doesn’t work—currently. Individual patients may apply for access to experimental treatments outside of a drug trial if they meet all three of the following criteria:

  • have a serious or life-threatening disease or condition;
  • have no other treatment options left; and
  • can persuade a qualified physician to deliver the treatment.

Under these circumstances, the FDA may, at its sole discretion, grant “compassionate use” of the new medication. But the program is marred by a prohibitively cumbersome application and documentation process, and the agency does everything it can to delay or block approval. It can even revoke permission after it has been granted—and does. How capricious can you get?

The issue is gaining momentum at the state level: more than two dozen states have approved so-called “Right-to-Try” bills—including California, where Gov. Jerry Brown just last month signed such a bill into law. We must throw our support behind the federal bill.

Action Alert! Write to your senators and urge them to support Sen. Johnson’s Right-to-Try bill. Please send your message immediately.



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