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February 2, 2016

A hopeful ‘signal’ of progress from the FDA

by: Carmen S. Scott

The Food and Drug administration is the oldest running consumer protection agency in the U.S. federal government, and it was created to serve the best interests of the public. Its functions began in 1906 with the passage of the Pure Food and Drugs Act, which banned damaged and misbranded food and drugs from being marketed to consumers. It became formally known as the FDA in 1930.

In recent history, however, the FDA’s disregard of important safety issues has made it appear more as an arm of the pharmaceutical and medical device industry than a governmental agency. These practices, unfortunately, may have allowed potentially dangerous medical devices and prescription drugs to enter the marketplace.

The FDA’s long-term relationship with the pharmaceutical and device industry

This all started in 1980’s when the U.S. experienced a drug lag, due to the lack of resources available to the FDA. For much of the 20th century, drugs and devices were approved at a much slower pace in the United States than in Europe, so much so that drugs were available to Europeans in many cases more than a year before being approved in the States.

Patients, doctors and advocacy groups worried that this lag prevented Americans access to important medicines and technologies, Congress passed the Prescription Drug User Fee Act (PDUFA) of 1992. This act requires pharmaceutical companies to pay an application fee for their products to be reviewed by the FDA. This increase in revenue allowed the FDA to hire new drug reviewers and support staff, bringing the U.S. medical market up to speed with Europe.

Lost sight of purpose

It is possible that the passage of PDUFA led the FDA down a dark path to becoming an extension of the drug and device industry instead of a federal, for the people, agency. By being partially funded by the medical device and pharmaceutical industry as opposed to solely through the U.S. Treasury, it is possible to see how the FDA may be more inclined to put the industry’s wants over the consumer’s needs.

Hopefully, that may now be changing. A new FDA communication system is being introduced that will provide important, timely safety updates on prescription drugs and medical products for the public, not just for those adept at researching and uncovering such information.

The FDA has drafted a ‘Public Notification of Emerging Postmarket Medical Device Signals’ or ‘Emerging Signals’ program. This proposed guidance is a first step in the FDA’s effort to better communicate information regarding emerging signals to patients, consumers and physicians about medical devices that are increasingly being reported for negative or harmful side effects. The goal is that this notification will better inform patients, doctors and others when the agency is in the early stages of monitoring or analyzing a product that has the potential to injure or harm, rather than at a later stage as the FDA does now.

I think this proactive approach may finally allow the agency to live up to its purpose, to protect the health and safety of American citizens. This effort is too late for some. We’ve seen countless examples of how this new system could have benefited thousands of Americans who take prescription drugs or have had a medical device implanted.

Here are three examples in which the FDA could have communicated safety warnings earlier:

Xarelto®

Xarelto was originally approved by the FDA as a blood thinner in 2011 to reduce the risk stroke specifically following hip or knee replacement surgeries. However, since then the Xarelto label has changed or added multiple warnings regarding patient safety, including stripping the recommended use in those with prosthetic heart valves or those with poorly functioning kidneys. While these warnings were made available on the website capable of being navigated by professionals, the public received little information on these important changes. Throughout these changes, the drug remained widely advertised, prescribed and administered.

Transvaginal mesh

In the past, the FDA has privately investigated adverse products, these investigations can take years of trial studies to gather the necessary data. I believe this lack of communication with physicians and the public has led to more harm than good. Take transvaginal mesh for example. Pelvic mesh was approved by the FDA for treating stress urinary incontinence (SUI) in 1996 and was cleared by the FDA as a moderate risk treatment in 2002 as a treatment for pelvic organ prolapse (POP). However, between 2005 and 2010, almost 4,000 injuries related to pelvic mesh were reported to the FDA.

In 2008 the FDA cautioned patients of risks after receiving more than 1,000 reports of adverse events including infections, pain, mesh erosion, vaginal scarring, pain during intercourse and bowel and bladder perforation after undergoing the procedure. In 2011 the FDA issued another warning noting that they had received almost 2,000 reports of adverse events stressing that complications were not rare. It wasn’t until 2011 that the FDA recalled certain transvaginal mesh devices.

During this time many studies proved that there are many other treatments for POP, however I think, due to the FDA’s lack of communication with the public, doctors were still recommending mesh and patients were still having it implanted rather than choosing an alternative.  

Essure®

Thousands of women are demanding that the permanent birth control device Essure® be recalled by federal drug regulators after allegedly causing formerly healthy women, whom were implanted with the device, to become chronically ill and forced to suffer excruciating pain. According to the device manufacturer Bayer, more than 750,000 American women have been implanted with Essure® to date. Of that, more than 5,000 adverse events, or unfortunate medical occurrences, have been reported to the FDA including 11 deaths, five of which were fetal deaths.

Simply arming doctors and women with such vital information has the potential to save a patient from suffering unnecessary injuries or even save their life.  

Second Chances

While the FDA has only released a draft of the “policy,” the objective is to combat communication issues that have allowed thousands to be equipped with devices that are under investigation of causing harm.

According to the FDA, emerging signals are “new information about a medical device that is used in clinical practice: that the agency is monitoring or analyzing . . . That has the potential to impact the patient management decisions and/or alter the benefit-risk profile of the device.” The goals of this policy is to keep consumers and physicians on the same page as the FDA so that they can make better decisions for themselves or recommendations to patients.

The FDA has indicated that it will consider the following factors when evaluating and communicating about Emerging Signals:

  • “Seriousness of the adverse event(s)
  • Magnitude of the risk
  • Magnitude of the benefit
  • Strength of the evidence of a causal relationship between the use of a device and the adverse event
  • Extent of patient exposure
  • Whether there is a disproportionate impact on vulnerable patient population
  • Potential for preventing, identifying, monitoring or mitigating the risk
  • Availability of alternative therapies
  • Implications for similar or related devices
  • Anticipated time for completion of initial FDA assessment and development of recommendations
  • Accuracy and availability of information already in the public domain

The FDA will notify the public of emerging signals regarding a device or drug that has had numerous reports of adverse events. It is important to remember that notification of ‘emerging signals’ are only that, emerging signals, and not a recall. The FDA is at an early stage in investigating a device or drug and more research will be needed before deciding if a product is safe or needs a recall. The completed version of the FDA Public Notification of Emerging Postmarket Medical Device Signals will be available by February 2016.

While this is a step in the right direction, the FDA has a long road ahead before it can gain back the public’s trust.

We’ll continue to watch how the FDA rolls out this new initiative. In the meantime, I applaud them for recognizing there is a huge communication problem that needs addressing. I believe this is a major stride forward in how we can prevent unnecessary victims due to defective devices and dangerous prescription drugs.