This weekly column offers opinions on the latest pharmaceutical industry news.
Ted Cruz thinks the Food and Drug Administration is broken and he has a curious plan to fix it.
The presidential aspirant from Texas, along with fellow Republican Senator Mike Lee of Utah, recently introduced a bill called the RESULT Act that would drastically overhaul the process for approving drugs and medical devices.
Under the proposed law, the FDA would have to approve “life-saving” products for which is there an unmet medical need if those drugs or devices have already been endorsed in “trusted, developed countries,” including European Union member states, Canada, Israel, Australia, and Japan. The agency would have only 30 days to make a decision. And Congress could override an FDA rejection with a majority vote.
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“We need to tear down the barriers blocking a new era of medical innovation, and the primary inhibitor is the government itself,” Cruz said earlier this month upon introducing the RESULT act, short for Reciprocity Ensures Streamlined Use of Lifesaving Treatments. “It’s past time to unleash a supply-side medical revolution, so that instead of simply caring for people with debilitating diseases, we cure them.”
In short, Cruz wants to eliminate the proverbial red tape. This is a laudable notion and Cruz may be well intentioned, but he is misguided.
If the bill becomes law, Americans will likely find themselves treated with medical products that were approved with varying, and quite possibly, lower standards elsewhere. In effect, his legislation stands to jeopardize — not improve — public health.
“It’s a bad idea all around,” said Dr. Walid Gellad, codirector of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. “The risks greatly outweigh any benefits.”
To be sure, the FDA review process is not perfect. What is? But the agency is still considered the gold standard by which other regulators are measured. Rubberstamping an approval that was made in, say, Japan or Romania may speed access, but may not always ensure a medicine is safe or effective. Americans may want to ask themselves if they want to rely on regulators in other countries.
“It’s a bad idea all around.”
Dr. Walid Gellad, University of Pittsburgh
Consider thalidomide. In 1956, the drug was approved in several European countries as a sleeping pill, and was also prescribed for morning sickness. But the medicine was later found responsible for thousands of babies born with malformed limbs. Thankfully, an FDA reviewer refused to approve thalidomide, and the drug never entered the US market. Imagine what might have ensued if the agency had taken the approach Cruz envisions.
Another problem with the bill is that the FDA would likely be hard-pressed to make decisions in 30 days. Given its workload, the agency would need more money to meet such a goal. Right now, companies pay fees to help cover review costs. Would industry pay higher fees? Would Congress appropriate more funds to cover shortfalls? Is it realistic to think an FDA review can be comprehensive that quickly?
Perhaps the most troubling provision in the legislation is the notion that Congress should be permitted to override any FDA decision not to approve a product. Such a move would politicize the review process, especially as more patients and their families clamor for new treatments.
“You can just imagine the first time that Congress overrides an FDA decision and there are bodies in the street because of it,” said Robert Pollock, a former senior FDA official, who is now a senior advisor at Lachman Consultants. “It simply doesn’t make sense. Congress is not trained to do that work.”
Ironically, the bill arrives just as the FDA greenlighted 43 new medicines this year, the highest annual total in 20 years. What’s more, a recent study found the FDA took significantly less time than the European Medicines Agency to assess drugs designated for a priority review.
“This is really an unneeded piece of legislation,” said Ira Loss, who tracks the FDA for Washington Analysis, a consulting firm. “But there’s always someone unhappy with the FDA.”
That much is true. Some patient advocates, for instance, continue to complain the FDA impedes faster drug approvals. The so-called Right to Try movement, which is quarterbacked by a conservative think tank, has helped pass laws in more than two dozen states that seek to cut the FDA out of the process of making experimental treatments available to desperate patients.
Right now, Cruz has a higher-profile perch than most from which to try to revamp the agency. But his ideas are nothing more than pandering to voters who believe the agency is part of the problem, not part of the solution.
Grandstanding may be de rigueur during an election, but this should not be confused with good judgment. The RESULT Act is more likely than not to yield only unwanted results.