Many Drug Makers ‘Not Completing FDA Approval Process’

    New research has revealed that many of the pharmaceutical drugs that are available on the market in the US under the Accelerated Approval Program have not completed the Food and Drug Administration’s (FDA’s) approval process.

    Sharing the research, which was first published in the INFORMS journal Manufacturing & Service Operations Management, News Medical explained that this is because of a process introduced to accelerate the availability of new treatments.

    Back in 1992, the FDA introduced its Accelerated Approval Program. This allowed drug manufacturers to bring certain new drugs to market without full FDA approval. However, a condition of these drugs being granted full FDA approval was that they would carry out post-market studies to prove a drug’s effectiveness.

    Only once these studies have been completed can full FDA approval be granted. The researchers found that, between 1992 and 2008, 36 per cent of post-market studies hadn’t been completed.

    What’s more, half of the incomplete studies took an average of five years to even begin.

    Liang (Leon) Xu, professor of supply chain and analytics at the University of Nebraska-Lincoln College of Business and lead author of the study, told the news provider that there’s currently little incentive for manufacturers to conduct these post-market studies.

    He said they are “not easily enforced and they are expensive”. Professor Xu added: “Withdrawing a drug from the market takes time and without proof of ineffectiveness cannot be enforced immediately.”

    But his team has come up with a potential solution to this issue that would encourage drug manufacturers to carry out their post-market studies in a timely fashion. They recommend replacing the current fixed fee structure for new drug application reviews with a fee system that’s tied to a post-market study deadline.

    In a statement, the FDA stressed the differences between its different expedited drug approval programs, pointing out that the accelerated approval pathway is just one that is used in specific circumstances.

    It said that any drugs that go through this program “meet FDA standards for safety and efficacy”. The difference for drugs that go through the accelerated approval pathway, as opposed to one of the other expedited programs, is that they are able to use a surrogate endpoint rather than a clinical endpoint.

    The FDA added that accelerated approval is “especially useful when the drug is meant to treat a disease whose disease course is long and an extended period of time is needed to measure its effect”.

    This is why a post-market study needs to be conducted. The organisation also stated: “Note that the purpose of such studies is to verify that the drug meets a clinical endpoint that shows improvement in how individuals feel, function or survive.”

    Should no clinical benefit be demonstrated in the post-market study, the FDA will withdraw a drug from the market, and, in fact, has done so in the past.

    The drug approval process, whether in the US or elsewhere in the world, is often long and complex, even when it involves an expedited pathway.

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