Is the New FDA Draft Guidance Enough to Protect Consumers?

Pharmaceutical companies across America have been scrutinized for years over their reluctance to release clinical trial data to the public. Many people have argued that patients should have open access to this information when deciding to try new drugs, and that it’s wrong for these companies to keep such important knowledge hidden.

On September 21, 2018, they FDA published a new draft guidance that was intended to make clinical trial data more accessible. Although the document promises stiff fines for pharmaceutical companies that don’t release their data, it still fails to make information easily accessible to the public. Here’s what you need to know about this controversial new draft guidance.

The Public Deserves to be Informed

Current data shows that only 59.5% of clinical trials in the United States are releasing their data to the public. According to the new draft guidance, pharmaceutical companies are required to submit their results to the ClinicalTrails.gov data bank. If they don’t submit their clinical trial data to this database, they could face high fines. Hopefully, this will encourage researchers to release information to the public.

Will Inspections Be Enough?

The FDA plans to enforce the new disclosure requirements by conducting inspections of drug development companies under their Bioresearch Monitoring Program. Unfortunately, this still means that the public will have limited knowledge about trial data uncovered during inspections.

The ClinicalTrials.gov site warns consumers that “Listing a study does not mean it has been evaluated by the U.S. Federal Government.” This means that even if researchers publish their findings, they aren’t necessarily being held accountable. Consumers are expected to trust the Bioresearch Monitoring Program without knowing what they’ve actually uncovered in their investigations, and many patients will inevitably take issue with this.

Will High Fines Discourage Future Violations?

 Pharmaceutical companies have the chance to earn the trust of consumers by releasing data on time, but it remains to be seen if they’ll take advantage of this opportunity. And if the trust of consumers isn’t enough, the fines may encourage them to disclose results in a timely manner.

The new draft guidance states that pharmaceutical companies may face fines of up to $10,000 per day, per study for not disclosing clinical trial data to the public. Fines will be calculated based on the severity of the infraction, the company’s ability to pay, and several other factors. Additionally, the names of non-compliant companies will be added to a public list.

 Take a Stand and Contact the FDA

In the past, clinical trial results were known to slip through the cracks and fall off the public radar. These new regulations are intended to prevent that—but some are claiming that they still fail to provide adequate public access to clinical trial data. Luckily, if you’re concerned about the new draft guidance falling short, you have until November 20, 2018 to contact the FDA to voice your concerns.

 

Sources:

  1. https://www.outsourcing-pharma.com/Article/2018/10/10/Clinical-trial-transparency-There-is-no-one-answer-to-what-must-be-disclosed
  2. https://www.federalregister.gov/documents/2018/09/21/2018-20560/civil-money-penalties-relating-to-the-clinicaltrialsgov-data-bank-draft-guidance-for-food-and-drug
  3. https://www.outsourcing-pharma.com/Article/2018/10/08/FDA-guidance-on-clinical-trial-data-disclosure-falls-short-while-noncompliance-remains-high

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