Washington (February 22, 2016) – Senators Edward J. Markey (D-Mass.), Joe Manchin (D-W.V.) and Richard Blumenthal (D-Conn.) today said they will vote against the nomination of Dr. Robert Califf to head the Food and Drug Administration (FDA). Senators Markey and Manchin were joined today at the U.S. Capitol by law enforcement, public health and medical leaders in calling for reforms at the FDA to help address the prescription drug and heroin crisis. In 2014, nearly 30,000 people died of an opioid overdose. The Senators also pledged to take their opposition to Dr. Califf’s nomination to the Senate floor before the final vote this week.

“The FDA is supposed to be our nation’s pharmacist, but right now, it is prescribing dangerous and addictive painkillers without limits, without supervision and without consequence,” said Senator Markey. “We need the leader of the FDA to be a tough cop on the beat, not a rubber stamp approving the latest Big Pharma painkillers that are the cause of this deadly scourge of opioid addiction and overdoses. The FDA must begin by agreeing to convene advisory committees for all opioid approval decisions, period. We are hemorrhaging lives by the day, and reforming the FDA is the first step needed to staunch the flow of suffering and death.”

“With 51 Americans dying every day due to an opioid overdose, the FDA now more than ever needs a champion who is committed to changing the way the agency handles opioids,” said Senator Manchin. “The FDA needs new leadership, new focus and a new culture. Dr. Califf’s past involvement with the pharmaceutical industry indicates that he will not be this person.  He will not have the impact or leadership capabilities that the nation needs to stem the tide of the opioid crisis. It is for these reasons that I am opposing Dr. Califf’s nomination as the FDA Commissioner.”


“In the face of a spiraling opioid crisis, the FDA has utterly, abjectly failed to protect Americans,” said Senator Blumenthal. “Instead of desperately needed reform in opioid drug oversight, this nominee offers only more of the same. The FDA has not put the necessary regulatory controls in place to protect public health and ensure access to safe medications. Rampant opioid addiction is sweeping our county like a hurricane—leaving overdose deaths and heartbroken families in its wake. We must address this crisis with the same sense of urgency we use when responding to a natural disaster.”


“Law enforcement has stepped into this conversation because we see the horrific effects of addiction on families, communities and society, and we said ‘no more’,” said Gloucester, Massachusetts Police Chief Leonard Chief Campanello. “If we in law enforcement can change how we do business to work with our citizens, then we should hold accountable those entities whose job it is to regulate the drugs that directly lead to death in this country. Law enforcement sees the suffering of adults and children. But we must begin by asking the question of why the only entities who do not see the approval of Oxycontin for the past eleven years as reprehensible and irresponsible are pharmaceutical companies and the FDA. As law enforcement, we promise to hold accountable those who perpetuate this disease and continue to be part of the problem and not the solution.”


“As a close observer of FDA’s opioid decision-making for many years, I have watched the agency repeatedly put the interests of opioid manufactures ahead of public health, even in the face of a worsening addiction epidemic,” said Dr. Andrew Kolodny, Chief Medical Officer of Phoenix House Foundation. “The FDA’s handling of opioids may be one of the best examples in history of regulatory agency failure leading to a public health catastrophe.”


“The bottom line is that we need to go at this problem from every angle and with the help of everyone – family assistance, counseling programs, drug courts, consumer and medical education, law enforcement support, state and federal legislation,” said Sheriff Rodney Miller, Executive Director of the West Virginia Sheriff’s Association. “We’re doing everything humanly possible from a police standpoint. With continued support and tireless work from everyone, we can beat this epidemic once and for all. We thank Senator Manchin and Senator Markey for fighting for change at the FDA that is going to help stop the addictive drugs from hitting our communities.”


“Opioid addiction has reached epidemic proportions, now killing more Americans each year than automobile accidents,” said John Rosenthal, c-founder of the Police  “The American people need an FDA that is a watch-dog not a lap-dog for the pharmaceutical industry. The FDA should revoke their irresponsible approval of OxyContin for children and Zohydro, which their own advisory committee recommended against.”


“We believe that more needs to be done to properly address this crisis. We support the efforts of Senator Manchin and Markey to change the culture at the FDA so that we can stop these addictive prescription drugs from harming our communities,” said Ronda Eddy, Director of the Jefferson Day Report Center in the Eastern Panhandle of West Virginia. “The health and safety of our families and communities in West Virginia and in Jefferson County depends on ending the drug abuse epidemic.”