FDA Needs Teeth: How non-compliance is dangerous for patients

FDA Needs Teeth

Historically, the FDA has often been perceived as a powerful US agency that protects the public. What most members of the public do not know is that the FDA has no enforcement powers when a manufacturer has violated a rule in a federally regulated activity.

 

My work with the FDA

I have worked for the United States Food and Drug Administration (FDA) as a Special Government Employee (SGE) and consumer representative since 2016.  I also have personal, first-hand experiences as a harmed patient, so I understand the frustrations of other harmed patients who need the FDA to listen and make necessary changes to improve patient safety.

To be fair, in my time at FDA, the agency has made changes that improve patient safety, yet it continues to lack measures to hold pharmaceutical companies and medical device makers accountable for FDA approved products that are proven unsafe.

 

How the panels work

FDA Center for Devices and Radiological Health (CDRH) advisory panels review and analyze data from both the FDA and the pharmaceutical industry, and are given briefings prior to panel hearings.  On the day of the hearings:

  • Both FDA and industry representatives give presentations and listen to the testimony of both harmed patients and those who have benefited from the products.
  • Panel members consider this information and decide whether the risks outweigh the benefits.
  • Panel members deliberate and make recommendations to the FDA.

 

What happens when there are violations?

If there have been violations of the Food, Drug, and Cosmetics Act, aka The Act* , the FDA sends warning letters to manufacturers that have violated rules in federally regulated activities.

While the letters communicate the agency’s position on a matter, they do not commit the FDA to an enforcement action.  The FDA does not consider a warning letter a final action on which a company can be sued.  Companies are given the opportunity to voluntarily take corrective action, but have little incentive to comply.

 

Testimony from a survivor

I’ve sat on many advisory panels, but one of the most notable panel hearings that illustrates the need for accountability was on March 25 and 26, 2019. The advisory panel met to discuss Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) . BIA-ALCL is a specific cancer caused by breast implants; it is different from breast cancer.

One particular testimony from survivor Roxanne Vermeland–one of over 80 speakers urging FDA to take action–stuck with me.  She is a survivor of both breast cancer and BIA-ALCL.

After surviving breast cancer and needing breast construction, she then developed BIA-ALCL from the implants. Last year, her BIA-ALCL advanced to stage 4 when it spread to her lungs. Thankfully, chemotherapy put her in remission.

While the FDA agrees that breast implants have more risks than benefits, their actions on the matter have been limited.  For example, device makers Mentor , Sientra , Allergan, and Ideal** have not complied with warning letters.

 

Limited actions – Too little, too late

Allergan issued a worldwide recall*** on macro-textured implants after the advisory panel met, but before the FDA issued a warning letter.  The warning letter was issued after the device recall because the FDA wanted recalls of ALL breast implants Allergan made, and because Allergan failed to complete long term studies as required.  Allergan still hasn’t completed the studies.

Ten months after the recalls, Allergan attempted to track down the women who still have their implants.  Many of the survivors said they found out about the recall through social media or news reports, not from the FDA.  By their own admission, FDA states that warning letters are not the final action, which brings up an obvious question:  Why isn’t there a final action?

 

The need for accountability

When companies fail to respond to warning letters, there are effectively no consequences from the FDA, resulting in continuing dangers to patients and consumers.

To be effective, the FDA needs to be more clear about messaging, follow up with manufacturers that do not comply, and have swift, strict consequences for non-compliance.  These consequences might include substantial fines for manufacturers that do not comply with regulations.

Under the current model, companies pay no fines, and  the FDA gets 50% of its funding from drug companies that pay to fast-track their products.  Fast tracking means the FDA will approve a product with little or no testing for safety and effectiveness.  This obvious conflict of interest comes at a cost to patient safety.

 

Summary

Without a strict accountability model, including consequences for companies that fail to comply with regulations, the FDA risks becoming irrelevant and ineffective, and failing in its role to protect patients and  consumers.

Notes

* The FDA was granted authority by the laws of The Act. Chapter III of The Act is called Prohibited Acts and Penalties. This section contains both civil law and criminal law clauses. Most violations under the act are civil, though repeated, intentional, and fraudulent violations are covered as criminal law. One notable 1943 Supreme Court case called United States v. Dotterweich, in which The Act uses strict liability.

** Mentor (3/19/19): https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mentor-worldwide-llc-acclarent-573520-03182019

Sientra (3/19/19): https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sientra-inc-573436-03182019

Allergan (5/28/20): https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/allergan-607690-05142020

Ideal (5/28/20): https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ideal-implant-incorporated-606103-05142020

*** In 2019, Allergan issued a worldwide recall of one specific breast implant called Naturelle textured implants around the time of the March 25 and 26, 2019 hearing. The FDA sent the warning letter a year later because FDA thinks all breast implants cause the manmade cancer and that there should be a recall on other breast implants Allergan makes, not just the one.  Allergan, per their premarket approval application, was required to do a 10 year post approval study to follow up with patients who got sick from implants.  Allergan failed to do so.  The warning letter tells Allergan that they failed to uphold the conditions of their device approval.  They never did the 10 year study, a significant violation.

 

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