March 01, 2016

Manchin Speaks at FDA Public Meeting on Opioid Epidemic

Washington, D.C. – U.S. Senator Joe Manchin (D-WV) spoke at a public meeting held by the Food and Drug Administration’s (FDA) Science Board today. He discussed the FDA’s past actions, which have not considered the public health impact or assessed the realities of the deadly opioid epidemic when approving dangerous opioid medications.

“The FDA serves a critical role as the agency that oversees the approval of these addictive drugs, but time and time again has failed to consider public health when approving opioids,” Senator Manchin said. “I hope that this meeting today will be the first step the agency will take to begin doing everything humanly possible to reverse the trend of prescription drug addiction.”

Read Senator Manchin’s remarks as prepared for delivery below:

Thank you for inviting me here today to talk about the public health impact of opioid addiction and overdose death. As you know, I have been very critical of the role that the FDA has played in this epidemic, which has killed almost 200,000 Americans since 1999 and took the lives of 51 Americans every day of 2014.

The FDA serves a critical role as the agency that oversees the approval of these addictive drugs, but time and time again has failed to consider public health when approving opioids. I hope that this meeting today will be the first step the agency will take to begin doing everything humanly possible to reverse the trend of prescription drug addiction.

As the senior Senator from West Virginia, I have seen firsthand the devastating effects of prescription drug abuse on individuals, families, and communities in my state. Drug overdose deaths have soared by more than 700 percent since 1999. We lost 600 West Virginians to opioids last year alone.

For years, the FDA delayed before finally agreeing to reschedule hydrocodone. My first three years in the Senate were consumed with getting FDA to come around on this important step.

Since the change finally went into effect, we’ve seen the number of prescriptions for hydrocodone products such as Vicodin and Lortab fall by 22%.  That’s almost 26 million fewer prescriptions or 1.1 billion fewer pill.

And yet, after finally taking that important step, the next day, the FDA approved the dangerous drug, Zohydro, even when its own experts voted 11-2 against approval. This drug has ten times the hydrocodone of Vicodin and Lortab, with the capability of killing an individual in just two tablets.

Disturbingly, the FDA responded to the criticism surrounding the approval of Zohydro by bypassing the advisory committee process altogether. The agency approved three powerful opioids – Targiniq, Hysingla, and Morphabond – was well as the use of OxyContin for children as young as 11 years old all without consulting an advisory committee.

I know that today is part of an effort to change this dangerous past, but I highlight these examples to illustrate the FDA’s past inability to consider public health and assess the realities of this deadly epidemic.

I firmly believe that there are simply too many opioid pills on the market. According to the NIH, in 2012, more than 259 million prescriptions were written in the United States for opioid painkillers. That equals one bottle of pain pills for every U.S. adult.

Overall, the FDA’s approval rate for new drugs and new marketing claims is dramatically higher than it was just a few years ago. In 2008, companies filing applications to sell never-before-marketed drugs were denied 66% of the time. In the first eight months of 2015, the approval rate was 89%.

In 2008, the FDA’s approval of new marketing claims for existing drugs was 56%. In the first 8 months of 2015, it was 88%. This includes approving OxyContin for children as young as 11.

These approval rates represent a problematic shift in the FDA’s relationship with the pharmaceutical industry, including opioid manufacturers. The FDA should instead focus on building a relationship with the millions of Americans impacted by prescription drug abuse.

In fact, there are currently 52 opioid extended-release and long-acting opioid medications that have been approved by the FDA and at least two dozen short-acting opioid medications. With these existing medications, we can currently treat everything from short-term, acute pain to excruciating cancer pain.

Despite these numbers, the FDA has continued to approve new opioid drugs – not one of which, despite some having abuse deterrent properties, is safer and less addictive than the opioids already available.

In addition, there have been critical questions raised – including by the NIH director, Dr. Francis Collins – that there is very little evidence to show that opioids help and are safe when used long-term for chronic pain.

Most opioid-related studies have lasted less than 12 weeks and many less than 6 weeks, and no placebo-controlled trial continued for even 6 months.

And many of these studies used “enriched enrollment,” a process approved by the FDA which removes patients with pre-existing opioid sensitivities from the trial and has made it easier for drug companies to demonstrate efficacy in medications that – in traditional studies – appeared to be hardly better than placebo and/or were poorly tolerated. Enriched enrollment skews results and seriously underestimates risks associated with the proposed drug involved in the clinical trial.

Despite all this – 90% of people with long-term, chronic pain are prescribed opioids – that’s approximately 8 million Americans – and they often take these drugs for years.

In 2014, we lost more than 18,000 people to prescription opioid overdose. This must stop, and the FDA must be part of the solution. You need to consider the unbelievable number of opioid drugs already on the market and the glaring lack of evidence that these drugs are useful to many of the patients who are taking them. The public health should be your number one consideration from this day forward.

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