The Facts About the FDA’s Questionable Practices

The Facts About the FDA’s Questionable Practices

Contributed to TLB by: The Children’s Health Defense Team

The FDA increasingly makes use of special programs to speed up its approval of new drugs and biologics.

These programs, ushered in through pieces of legislation such as the 1992 Prescription Drug User Fee Act (PDUFA) and the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), include:

  • Orphan Drug Act (1983): “Set up to encourage the development of drugs for rare diseases” (defined as diseases affecting fewer than 200,000 Americans)[1]

  • Fast Tracking (1988): Facilitates the development and expedites the review of “drugs to treat serious conditions and fill an unmet medical need”

  • Accelerated Approval (1992 and 2012): Allows for “earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint” (defined as “a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit”)

  • Priority Review (1992): Signals the FDA’s intention to “take action on an application within 6 months”

  • Breakthrough Therapy (2012): Expedites the development and review of “drugs that are intended to treat a serious condition,” where early clinical evidence indicates the potential for “substantial improvement over available therapy” for one or more “clinically significant endpoints”

Between 1983 and 2018, these legislative and regulatory initiatives “substantially changed drug approval at the FDA.”

According to a January 14, 2020 “special communication” in JAMA:

  • New biologic product approvals increased from a median annual number of 2.5 to 12 (a 380% increase) from the 1990s to 2014-2018.[2]

  • The proportion of drugs approved via the Orphan Drug Act more than doubled, going from 18% (1984-1995) to 41% (2008-2018).

  • In 2018, four out of five of these drugs (81%) benefited from at least one form of expedited FDA approval.

The PDUFA allows pharmaceutical companies to make payments to the FDA (“user fees”) in exchange for expedited approval of drugs and biologics.

User fees introduce potential conflicts of interest into the FDA’s regulatory process.

  • Steven Joffe, MD, MPH—Professor of Medical Ethics and Health Policy at the University of Pennsylvania Perelman School of Medicine—wrote in response to the JAMA findings:

There is certainly a potential for conflict in the [FDA’s] decision-making between the interests of the regulated industry and the interests of the public’s health, and so it would be better if the bulk of the agency’s budget came from the public—i.e., taxpayers—whose interests it is charged with protecting. However, I do not mean to imply that the agency’s decision-making has in fact been compromised by this arrangement.

  • Former FDA Principal Deputy Commissioner Joshua Sharfstein, MD wrote in an editorial accompanying the JAMA study:

The overall picture is not of a struggling FDA, but rather of a regulatory process that has evolved over time into a thicket of special programs, flexible review criteria, and generous incentives.

According to the JAMA study, “The FDA has increasingly accepted less data and more surrogate measures.”

  • In 2015-2017, just over half of new approvals (52.8%) were supported by at least two pivotal trials, versus 80.6% of new approvals in 1995-1997.

  • Nearly three in five pivotal efficacy trials (59.3%) for new drug approvals relied on surrogate measures for 2015-2017, versus 44.3% from 2005-2012.


Darrow JJ, Avorn J, Kesselheim AS. FDA approval and regulation of pharmaceuticals, 1983-2018. JAMA. 2020;323(2):164-176.

Herder M. What is the purpose of the orphan drug act? PLoS Med. 2017;14(1):e1002191.

Hlavinka E. FDA approvals: more efficient or more lax? Study finds shortened review times and bigger payments from industry. MedPage Today, Jan. 14, 2020.

Roy A. Biologic medicines: the biggest driver of rising drug prices. Forbes, Mar. 8, 2019.

Sharfstein JM. Reform at the FDA—In Need of Reform. JAMA. 2020;323(2):123-124.

[1] Orphan drug status confers significant market advantages: “Due to lower R&D costs . . . , expedited regulatory reviews, and minimal competition . . . , rare-disease-targeting orphan drugs are now amongst the most expensive and profitable drugs on the market in the world.”

[2] Biologics (which include vaccines) represent 37% of net drug spending in the U.S. and, since 2014, have accounted for 93% of the growth in net drug spending. Patent protections for new biologics (which get 12 years of exclusivity) “mean months or years of higher prices.”


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The above article: The Facts About the FDA’s Questionable Practices originated on Children’s Health Defense and is published here by contribution and with attribution to the author, the Children’s Health Defense Team, and website



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