NJ slams FDA on conflicts of interest

By Nick Taylor

- Last updated on GMT

Related tags: Clinical trial, Food and drug administration

New Jersey’s attorney general has called on the FDA to stop the “rampant undisclosed financial conflicts of interest” in clinical trials.

Anne Milgram, New Jersey’s attorney general, appealed to the US Food and Drug Administration (FDA) after settling a case with Synthes, which gained pre-market approval from the agency “even when the financial conflict disclosures were plainly inadequate​”.

The settlement with Synthes requires the company to ​disclose any future payments to, or company stock held by, physicians conducting its clinical trials.

In addition the company must pay physicians “fair market value compensation​”, which cannot be done in company shares, and disclose all financial interests directly to health care facilities serving as clinical trial sites.

This has been hailed by Milgram as a template for the entire industry, which would stop the practices that, in the NJ’s attorney general’s opinion, is “simply wrong”.

Milgram added: “It is outrageous that doctors who are testing and, in many cases, recommending the use of certain high-risk medical devices are being compensated with stock in the very companies that make the devices.

All patients – but especially those considering high-risk devices such as spinal disc replacements -- deserve honest, objective clinical trial information about the products available.We cannot allow financial conflicts of-interest to infect the clinical trial process. It is a betrayal of the public trust, and has the potential to jeopardise patient well-being.”

“FDA did nothing to regulate these conflicts”

The State of New Jersey launched an investigation into the financial conflicts of interests of the investigators participating in the clinical trials for Synthes in February 2008.

During the investigation it was revealed that the majority of physicians working on the clinical trial had significant investments in the product being tested, which would be worthless if it failed to gain regulatory approval.

Synthes failed to adequately disclose these conflicts of interest, which Milgram believes “should have been obvious from even a cursory review of its FDA submissions​”.

Consequently Milgram has written to Joshua Sharfstein, then acting commissioner at the FDA, calling on the agency to adopt the agreement with Synthes as part of “best practices​” for the industry.

Related news

Show more

Related products

show more

Vaccine Innovation in the Era of COVID19

Vaccine Innovation in the Era of COVID19

Covance Patient Safety | 01-Oct-2020 | Sponsored Link

During this time of worldwide crisis, there is an increasing demand for the acceleration of a vaccination for COVID19. Regardless of the great recent advancements...

What to consider when working with CRFs

What to consider when working with CRFs

Formedix | 21-Sep-2020 | Technical / White Paper

For a study to be successful, data collected must be correct and complete. To be correct and complete, forms must be well planned with meticulous attention...

Lessons Learned: Clinical Trials During a Pandemic

Lessons Learned: Clinical Trials During a Pandemic

PCM TRIALS | 01-Sep-2020 | Technical / White Paper

In a recent survey of clinical trial professionals (including pharmaceutical sponsors, CROs, site representatives and vendors), respondents reported that...

Related suppliers

Follow us

Products

View more

Webinars