FDA reviews go faster — but with less proof drugs are safer or more effective

darrow-300x168For anyone concerned with the quality and safety of prescription medications, this may be an especially displeasing commentary from a pharmaceutical expert about drugs raced to approval now:  “Some of them are really great,” the professor observed. “And some of them [are] not so great. And a lot of them are very expensive.”

That quote, by the way, comes from a news report by NPR on so-called reforms of the federal Food Drug and Administration prescription drug oversight process. Big Pharma has howled for some time now at politicians, regulators, and the public for fixes to the system — and the industry has gotten its way.

Now, as NPR reported, based on a new study posted online on the JAMA Network:

“The [FDA] has gotten faster at approving new prescription drugs over the past four decades, but the evidence it relies on in making those decisions is getting weaker … As a result, there are more cures and treatments on the market but less proof that they are safe and effective.”

Jonathan Darrow, a lawyer with Harvard Medical School’s Program on Regulation, Therapeutics, and Law and lead author of the JAMA work that scrutinized FDA drug policies and practices for the quarter century since 1983 (shown above), told public radio that “”There has been a gradual erosion of the evidence that’s required for FDA approval.” As a result, patients and physicians “should not expect that new drugs will be dramatically better than older ones.”

Darrow and colleagues at Boston hospitals and research institutions found that “half of recent new drug approvals were based on only one pivotal clinical trial instead of the two or more that used to be the norm … And the reliance on surrogate measures — stand-ins for presumed patient benefits — has increased. In the case of cancer drugs, a surrogate measure could be shrinkage of tumors instead of improvements in survival after treatment,” NPR reported.

By accepting less evidence, federal regulators have slashed their once-rigorous oversight over prescription drugs, so that products in 2018 got through reviews in 10 months versus the 2.1 years it took in the late 1980s and 1990s.

That was before Big Pharma started spending big on lobbying to persuade members of Congress that drug approvals needed to be sped up, so beneficial innovations could benefit patients sooner. The argument had urgency, following too many medical experts’ lead-footed response to the HIV-AIDS crisis.

But Congress may have pushed the FDA too far, especially by creating significant financial incentives for the agency to expedite drug reviews. Critics have noted, for example, that makers can and do pay special fees — which have become a growing part of the FDA budget — not only regular but also speeded up drug reviews, as NPR reported:

“The FDA collected $29 million in fees in 1993, the year after Congress passed the Prescription Drug User Fee Act for the first time. The fees rose to $908 million in 2018. That year, industry fees amounted to about 80% of the money spent on FDA employee salaries for drug reviews, according to the study. ‘There is some concern about the incentives that this is created within the FDA,’ Darrow says. ‘And whether it has created a culture in the FDA where the primary client is no longer viewed as the patient, but as the industry.’”

The prof who offered to NPR that displeasing quote about rapidly approved drugs happens to be Joshua Sharfstein. He’s a doctor, a former principal deputy commissioner of the FDA, and now a professor at the Johns Hopkins Bloomberg School of Public Health. He wrote an accompanying editorial, also published in JAMA, arguing for another reconsideration and more reforms at the FDA with its drug approval processes. The agency and Congress may need to reevaluate whether expedited drug reviews make sense and safeguard the public adequately, rather than just benefiting Big Pharma.

2020 seems to be off to a fast start as a year when various groups and individuals will issue clarion calls — finally — for improved FDA oversight over Big Pharma and medical device makers. The New York Times editorialized on this very issue, almost in chorus with the JAMA study, saying this of the agency and its efforts:

“Too many prescription drugs and medical devices are being approved [by the FDA] with too little data on how safe or effective they are. And too many other products — like those containing CBD or THC, ingredients found in the marijuana plant — are being sold with no apparent oversight at all. Part of the problem is that the agency has too few resources and too little power to fulfill its key responsibilities. But it has also become profoundly vulnerable to political interference and other special interests. And a revolving door — FDA staffers frequently go on to lucrative jobs at the very companies they were tasked with policing — has hurt the agency’s credibility. So, too, have a string of high-profile public health crises. In just the past few years, the FDA has been faulted for its roles in the opioid epidemic (regulators allowed too many opioids on the market without properly flagging them as addictive or deadly) and a surge in youth vaping (the agency failed to keep untested e-cigarettes off the market or to establish the safety of these products, as millions began using them).”

In my practice, I see not only the harms that patients suffer while seeking medical services, but also the havoc that can be wreaked on them and their loved ones by dangerous drugs, especially of the prescription kind, and dangerous and defective products, notably of the medical variety. Doctors and hospitals play their own huge role in making the U.S. health care system the industrialized world’s most expensive — with Americans seeing far poorer health outcomes than their Western counterparts.

But public furor rightly has focused on Big Pharma’s relentless push to make its product prices soar — now far beyond the reach of far too many Americans, even those with solid and employer-provided health insurance. Despite repeated plans and exaggerated claims, politicians — notably President Trump and congressional Republicans — have failed to rein in prescription drug costs.

Instead, as CBS News reported:

“Three days into the new year, drug makers have already increased the list prices on hundreds of medications, with experts predicting more hikes in the weeks to come.  So far in 2020, prices on 411 drugs have increased an average of 5%, according to GoodRx, which tracks the cost of more than 3,500 drugs. Of the drugs that have seen rising prices, 407 were brand-name products and four were generic. The drug with the biggest cost increase so far this year: Neos Therapeutics’ Cotempla XR, a stimulant used to treat ADHD and narcolepsy, whose list price is up more than 13%. Other commonly prescribed drugs that are getting pricier include Eliquis (up 6%), often prescribed to prevent blood clots, and Humira (7.4%), used to treat inflammation in patients with autoimmune disease.”

Big Pharma has reaped big profits by targeting its research and development campaigns in making minor changes to existing drugs, and by focusing on high cost therapies aimed at a narrow few, especially patients with rare or extremely specific conditions. Makers have found cancer therapies highly lucrative and have raced into this area. But researchers who have gone back and examined the track records of expedited cancer drugs, for example, have not found them to make a convincing case that they either extended or significantly improved patients’ lives, even though many were extremely costly.

We’ve got a lot of work to do to swing the pendulum in Big Pharma oversight — away from accommodating wealthy corporations’ wishes to the nth degree and back to providing patients with safe, affordable, and accessible treatments that improve and prolong their lives.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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