As keen followers of the biotech and pharmaceutical industries, we naturally keep close tabs on the FDA. We’ve discussed in this space previously that we feel the FDA performs a truly valuable societal function very well, and we’re encouraged whenever we see the government facilitate the drug approval process – or at least get out of its way.
Yesterday, the US Senate passed two important bills that positively impact the future of the FDA as well as biotech and drug companies. The first of these, known as the “right to try” bill, is designed to facilitate access for terminally ill patients to experimental medications that haven’t yet been approved by the FDA. Senator Ron Johnson (R-Wisconsin), the sponsor of the bill, said, “Patients with terminal diseases ought to have a right to access treatments that have demonstrated a level of safety and could potentially save their lives,” as quoted by The Washington Post.
Provided that the drugs have at least undergone preliminary clinical trials and continue to be tested further, access will be given to patients who have tried all other available treatment options and who are ineligible to participate in ongoing trials of the desired medications. The bill passed by unanimous consent and now heads to the House.
Several news outlets reported that this bill’s passage was part of an agreement between Senator Johnson and Senator Lamar Alexander (R-Tennessee), the Chairman of the Senate Committee on Health, Education, Labor & Pensions, to ensure Senator Johnson’s support for the second bill – the key funding reauthorization measure for the FDA. This “user fee” reauthorization bill – which passed by a 94-to-1 margin, with Senator Bernie Sanders (D-Vermont) offering the lone “Nay” vote – governs how much pharmaceutical companies and medical device manufacturers pay in fees to the FDA to support the approval and oversight processes of prescription drugs, generic drugs, medical devices and biosimilar drugs for the next five years.
Senator Patty Murray (D-Washington), who said the FDA vote showed “how Congress can actually work together on health issues and solve challenges.” Photo credit: Al Drago for The New York Times.
The funding reauthorization bill has already passed the House, and the President is expected to sign the bill into law, according to the Regulatory Affairs Professionals Society. This bill was the culmination of a year of consensus forging, according to The New York Times, which quoted Senator Alexander: “This is a bill that’s been done the right way. It’s an example of the way the Senate is supposed to work.”
We applaud the Senate’s final moves before recess to support the FDA and to provide a lifeline for terminally ill patients. We wish the Senate a peaceful August, and we hope they return in September well rested and focused on how to work together for the good of the nation. “I think we can spend time thinking about what didn’t happen,” said Senator Lisa Murkowski (R-Alaska) to The Washington Post. “I don’t have enough hours in my day to do that. I’m just focused on what we’re going to be doing going forward.”
Read Next
