In an attempt to salvage his legacy, President Obama has given us another 11th-hour, 1,000-page-law: the 21st Century Cures Act.
Much like Obamacare, I’m guessing few who voted for this bill ever read it. And much like Obamacare, now that Congress voted for it, the American people will read this — little by little, to find out what’s in it. And chances are it is full of pork.
The Cures Act increases funding for the National Institutes of Health and the “Moonshot” program for cancer research, requested by Joe Biden in honor of his son, Beau, who died of brain cancer last year. It also supports fighting the opioid addiction and devotes more funding to mental health care. These are important health care issues worthy of additional resources.
The 21st Century Cures Act had the input of over 1,455 lobbyists and was one of the most heavily lobbied bills in the 114th congress.
But that’s just the façade of the bill. There are questionable goals written throughout the lengthy legislation.
The 21st Century Cures Act had the input of over 1,455 lobbyists and was one of the most heavily lobbied bills in the 114th Congress. It included input from at least 78 pharmaceutical manufacturers, 24 device manufacturers, and 26 biotech companies. The Pharmaceutical Researchers and Manufacturers of America (PhRMA), the trade group representing the pharmaceutical manufacturers industry, spent $24.7 million of its overall $30.3 million on lobbying for the act.
This bill decreases the time it takes for drugs to get to market by reducing clinical trial requirements and weakens the safety and efficacy of both drugs and medical devices. The McCain-Schumer bill of long ago failed for very similar reasons. It was a bad idea then, and it’s a bad idea now.
The 21st Century Cures Act also makes drug and device approvals more dependent on surrogate endpoints or biomarkers. The truth is, even the most rock-solid biomarkers still need outcome trials to make sure they don’t cause unrelated, untoward adverse events. In other words, a drug that lowers a patient’s diabetes is no good if it also gives the patient cancer.
I recently wrote in a different piece for LifeZette about the Food and Drug Administration already making controversial and even dubious regulatory decisions — in management, in drug approvals, in “right to try” legislation, and in publicizing adverse event reporting, especially over the last few years. No person or agency already making bad decisions should have billions of additional taxpayer dollars thrown its way.
Reforming the FDA is long overdue, but reform shouldn’t come from groups that are themselves regulated by the FDA. Additionally, it shouldn’t come in the form of a last-minute bill that is long, hasn’t been read by anyone, and has been rushed through Congress during the last couple of weeks by a president who is bitter at America and at his incoming rival.
The Cures Act, if it operates the way we’re told it should, could change the course of countless lives and many devastating diseases. But while we wait to see if that happens, patients need to know that this bill further weakens an already dysfunctional federal agency meant to protect consumers from harm.
Know what you may be signing up for, ask questions, and otherwise take good care of yourself.
Dr. David Gortler is a professor of pharmacology and a former Food and Drug Administration senior medical officer; he is now a pharmacology expert and FDA expert with FormerFDA.com. He was the former FDA health care policy adviser for the 2016 Ted Cruz presidential campaign.