April 08, 2015

Manchin Delivers Remarks at National Prescription Drug Abuse Summit in Atlanta

Manchin announces he will introduce two bills to help curb prescription drug abuse

Charleston, W.V. – Today, U.S. Senator Joe Manchin (D-WV) delivered remarks at the National Prescription Drug Abuse Summit in Atlanta, Georgia to discuss the importance of combatting the prescription drug abuse epidemic and to announce two new pieces of legislation to help curb substance abuse, which will be introduced in the coming weeks. The summit, which hosted nearly 1,400 professionals, is the largest national collaboration of federal, state and local professionals seeking to address prescription drug abuse, misuse and diversion.

Senator Manchin said, in part, “Our nation has reached a crisis point, and ignoring the problem is simply unacceptable. We have a responsibility to this great nation of ours – especially to our children – to win this war on prescription drug abuse.

“Prescription drug abuse is the fastest growing drug problem in the United States, and it is claiming the lives of thousands of Americans every year. According to a report issued by the Centers for Disease Control, the death toll from overdoses of prescription painkillers has more than tripled in the past decade. More than 40 people die every day – every single day – from overdoses involving narcotic pain relievers. These prescription painkillers kill more Americans than heroin and cocaine combined.

“But it is especially tough in my home state of West Virginia, which has the highest drug overdose death rate in the country. Nearly 90 percent of those deaths are linked to prescription drug abuse.  This is simply unacceptable. The fight is far from over, but together, we will beat this epidemic, save hundreds of thousands of lives and give back so many of the lives that were once lost to drug abuse.”

Senator Manchin announced that he will introduce the Prescription Drug Abuse Prevention and Treatment Act and the FDA Accountability for Public Safety Act when the United State Senate returns after recess.

The Prescription Drug Abuse Prevention and Treatment Act:

Establishes a Consumer Education Campaign: Authorizes $15 million per year from 2016-2020 to establish a grant program for states or non-profits to conduct culturally sensitive consumer education about opioid abuse.

Strengthens Medical Practitioner Education: Strengthens training requirements for medical practitioners eligible to prescribe opioids or participating in opioid treatment programs. The practitioner must complete at least 16 hours of training every three years on 1) the treatment and management of opioid-dependent patients, 2) pain management treatment guidelines, and 3) early detection of opioid addiction.

Provides Law Enforcement with Access to Necessary Information: Requires states to provide law enforcement officials information from the prescription monitoring program database on any individual who is the subject of an active drug-related investigation.

Prevents Prescription Drug Abuse Under Medicare Part D: Authorizes Medicare Part D Prescription Drug Plan sponsors to establish a drug management program for Medicare beneficiaries deemed at-risk of prescription drug abuse.

The FDA Accountability for Public Safety Act:

Holds FDA Accountable for Opioid Drugs Approved: Requires a measured response to ensure that the experts’ voices are heard when the FDA is considering new, dangerous opioid medications.

- All opioid medications would be subjected to advisory committee review and recommendation before the FDA makes a decision on approving an opioid.

- If the Advisory Committee does not approve of an opioid medication due to concern over consumer health and safety – just as the Committee acted with respect to Zohydro – the FDA Commissioner would be required to make the final decision regarding drug approval.

- The FDA must submit a report to the Chair and Ranking Member of the relevant Committees that includes medical and scientific evidence regarding patient safety that clearly justifies why they ignored the Advisory Committee’s recommendation, and it must also include any conflicts of interest that FDA officials involved in the decision may have. The FDA must also submit a copy of this report to any Member of Congress who requests a copy.

- The FDA Commissioner would be required to testify before Congress as to why the FDA ignored its own Advisory Committee at the request of the appropriate Committee.

- Distribution of the drug would be prohibited until the report is submitted to Congress.