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Jan. 21, 2020, 6:15 a.m. EST

Harvard Medical School researchers allege ‘erosion’ of standards at FDA, criticizing shorter drug-review times

‘The FDA has increasingly accepted less data and more surrogate measures, and has shortened its review times,’ according to a new study in JAMA

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By Meera Jagannathan, MarketWatch


MarketWatch photo illustration/iStockphoto
'There has been an accumulation of special FDA programs over the past 40 years that reduced the amount and the quality of the evidence that’s required for drug approval,' said Jonathan Darrow, lead author of the study published in the latest edition of JAMA.

The FDA is approving new drugs more quickly than ever, and using less-stringent standards to determine whether those drugs actually work, according to a new study published in the peer-reviewed JAMA , the journal of the American Medical Association.

Lead study author Jonathan Darrow, a faculty member at Harvard Medical School, told MarketWatch there had been “an erosion of evidence standards at the FDA” over the past four decades, as FDA programs aimed at speeding up drug development and approval proliferated.

‘There has been an accumulation of special FDA programs over the past 40 years that reduced the amount and the quality of the evidence that’s required for drug approval.’

—A new study published in JAMA, the journal of the American Medical Association

“There has been an accumulation of special FDA programs over the past 40 years that reduced the amount and the quality of the evidence that’s required for drug approval,” he said. These programs have allowed some attributes of clinical evidence to be “more flexible” over time, he added.

The researchers examined FDA databases of approved new drugs and several FDA drug-approval programs, some of which were designed to get life-saving drugs to patients faster. They also looked at the issue of so-called user fees, which drug manufacturers pay to help fund FDA activities.

The study — coauthored by Aaron Kesselheim and Jerry Avorn, professors of medicine at Harvard Medical School — found, in part, that the share of new drugs approvals backed by at least two “pivotal trials” declined from 81% in 1995-1997 to 53% in 2015-2017. Pivotal trials are randomized clinical trials designed to determine whether a drug is effective and safe for humans.

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In response to the JAMA article, an FDA spokesman told MarketWatch that “based on a preliminary analysis, the FDA is concerned that the publication’s researchers do not adequately consider the marked changes in the types of drugs that the FDA now reviews and the patient populations targeted by development programs compared to those from 10-20 years ago, nor the type, quality, and extent of data the FDA routinely receives now compared to decades ago as is referenced in the publication.”

A spokesman for the FDA says it’s concerned that the researchers ‘do not adequately consider the marked changes in the types of drugs that the FDA now reviews.’

“For example, statistics used in the study that compare FDA actions on applications from recent years (such as the overall first cycle approval rate, or how many trials the FDA reviewed in an application, or use of surrogate endpoints) relative to actions decades ago, without considering these important factors, are potentially confounded and could result in inaccurate conclusions,” the spokesman said.

The FDA is conducting a detailed review of the JAMA article and its recommendations, he added, and plans to issue a more comprehensive response after analyzing the publication.

The study published in JAMA also found that the agency had increasingly relied on “surrogate” measures to predict actual clinical benefit (for example, using cholesterol levels to predict whether a drug would affect cardiovascular disease risk).

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Meanwhile, the median review time for standard and priority drug applications dwindled: It was 2.8 years in 1986-1992, 1.5 years in 1993-2005 and 1.2 years in the 2006 to 2017 period. In 2018, that review time sat at just 10 months for standard applications and less than eight months for priority applications.

“The FDA has increasingly accepted less data and more surrogate measures, and has shortened its review times,” Darrow and his co-authors concluded.

The median review time for standard and priority drug applications dwindled to 10 months in 2018 from 2.8 years three decades ago, the study found.

But for all of the programs designed to expedite FDA review times, there was little movement in overall drug-development time, Darrow added. This could be due to factors like an increase in application submissions for rare-disease drugs or “longer time horizons needed to establish efficacy,” the authors noted.

“These regulatory innovations have not clearly led to an increase in new drug approvals or to reduced total development times,” they wrote.

Darrow and his fellow researchers also found that annual fees received by the FDA from the pharmaceutical industry — a practice authorized by Congress in 1992 to raise money to speed up review times — had ballooned from $29 million in 1993 to $908 million in 2018, when around 80% of drug-review personnel’s salaries came from these user fees.

Of course, the FDA needs to be adequately funded in order to do its job, Darrow said. But “if the majority of funding of FDA personnel comes from industry, the FDA will begin to consider industry as its primary client rather than the public,” he added.

Darrow offered tips on how to be a smart consumer of prescription drugs:

Consider more than drug price. While price is an issue for many patients, Darrow also recommends asking, “Are the benefits of this product worth taking at any cost?” “If the answer is yes, then you can start thinking about whether the benefits are justified by the cost,” he said.

Do some digging. Scour a drug’s patient-package insert and the FDA website for information on the benefits and risks of the medication. Consumer Reports’ Best Buy Drugs provides scientific evidence on the effectiveness of prescription drugs, as well as information on cost and alternative therapies.

Ask about older, similar drugs. Ask whether there’s an older drug that is similar and would work about as well as what the doctor is prescribing. (Older drugs tend to have longer safety records, Darrow said.) Inquire to see if there’s a less-expensive alternative that is similar.

Look for bias. Has your physician ever accepted compensation from the drug’s manufacturer? Databases, including the Centers for Medicare and Medicaid Services’ Open Payments and ProPublica’s Dollars for Docs, can reveal potential ties to the pharmaceutical industry.

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