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Is Sponsor-Submitted Clinical Data Safe?

The U.S. Food and Drug Administration has a tricky task at hand when it comes to reviewing, evaluating, investigating and eventually approving prescription medications. Yes, the agency has a mission to ensure patient safety, and yes, a formal process must be followed before a medication can be marketed, but no, government workers do not conduct the clinical trials whose data leads to the approval process.

Instead, sponsors – also known as pharmaceutical companies and their supporters – pay for the clinical trials, leading to the logical perception that the data might be biased or even tainted. It is a reasonable conclusion that concerns consumers across the country.

In order to make good on its mission of ensuring patient safety, the FDA dispatches the Office of Scientific Investigations to check the accuracy, integrity and quality of all facts and figures. The division’s goals are twofold:

  • To verify the efficacy of data submitted in support of new drug applications.
  • To protect the rights and welfare of not only patients but also participants in clinical trials.

The OSI also inspects Institutional Review Boards, or IRBs, for compliance with safety standards.

“FDA investigators compare information that clinical investigators provided to sponsors on case report forms with information in source documents such as medical records and lab results,” explains Carolyn Hommel, an OSI consumer-safety officer, in a Living Safer Magazine article titled “The ABCs of the FDA Approval Process.”NDA

Several things are looked at, including whether the clinical trials were run using best practices, whether adverse events were reported and whether the human subjects followed proper protocol. If any errors or falsifications are found, the FDA has the right to issue a Notice of Initiation of Disqualification Proceedings and Opportunity to Explain, or NIDPOE. The warning letter “informs the recipient clinical investigator that FDA is initiating an administrative proceeding to determine whether the clinical investigator should be disqualified from receiving investigational products pursuant to the Food and Drug Administration’s regulations,” states the agency’s Web site.

OSI falls under the FDA’s Center for Drug Evaluation and Research, whose employees conduct as many as 400 inspections every year. Of those inspections, a reported three percent receive a NIDPOE.

Patients additionally are protected by the Drug Safety Oversight Board, or DSOB, also under the umbrella of the Center for Drug Evaluation and Research. The board tackles issues by meeting monthly with eight federal agencies, representatives of which give valuable input and expert advice about emerging problems and possible solutions.

“It’s often a combination of problems that prevent approval,” Dr. John Jenkins, of the Center for Drug Evaluation and Research, tells Living Safer Magazine. “Close communication with the FDA early on in a drug’s development reduces the chance that an application will have to go through more than one cycle of review. But it’s no guarantee.”

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