New SCPC Letter to Grassley, Leahy Urges Support For “Ensuring Patient Access and Effective Drug Enforcement Act of 2015” (S. 483)

DATE: February 3, 2016

Independent Long Term Care (LTC) Pharmacy Group Says Bill Recognizes Proper Balance Between Stemming Prescription Drug Abuse Epidemic and Preserving Patient Access to Critical Medications

Washington, DC – In a new letter to Senate Judiciary Committee Chairman Charles Grassley (R-IA) and Ranking Member Patrick Leahy (D-VT), the Senior Care Pharmacy Coalition (SCPC) urged support without amendment for the Ensuring Patient Access and Effective Drug Enforcement Act of 2015 (S. 483), introduced by U.S. Senators Orrin Hatch (R-UT) and Sheldon Whitehouse (D-RI).

“Given our experience and expertise, we are pleased to endorse S. 483 for recognizing the balance that industry and government must achieve to address the growing epidemic of prescription drug abuse while ensuring that patients have access to critical medicines,” writes SCPC President and CEO, Alan G. Rosenbloom.

“This important legislation would afford affected stakeholders additional opportunities to collaborate with federal and state government agencies to combat the abuse of prescription drugs while ensuring appropriate patient access,” his letter continued. “In particular, we support provisions of the legislation that allow regulated parties to work together with agencies to collaboratively develop remediation plans to any identified weaknesses in the distribution system.”

Rosenbloom noted S. 483 would amend the Controlled Substances Act in three important ways:

First, it would narrow and sharpen the definition of “imminent danger to the public health or safety,” which is the standard by which the DEA establishes whether any DEA applicant or registrant in the distribution chain for controlled substances may have its ability to distribute controlled substances denied, suspended or revoked;

Second, it would require that the DEA provide specific advance notice of violations before imposing penalties in most cases, and would allow the cited applicant or registrant to present a corrective action plan to the DEA, and to have the Attorney General review any such correction plan to determine whether denial, revocation or suspension should be discontinued or deferred for modification, amendment or clarification of the plan;

Third, it would require that the Secretary of HHS, through the Commissioner of the FDA and the Director of the CDC — in coordination with several other agencies including the DEA — report to Congress within one year after enactment concerning: Obstacles to legitimate patient access to controlled substances; issues with diversion of controlled substances; how collaboration among federal, state, local and tribal enforcement agencies and the pharmaceutical industry can benefit patients and prevent diversion and abuse of controlled substances.

“The SCPC is on record as supporting federal legislative efforts to eliminate drug abuse, particularly opioid abuse, and welcome efforts to attack such abuse wherever it occurs,” Rosenbloom stated. “We also believe that legislative and regulatory efforts in this regard must remain cognizant of the unique circumstances of patients who receive care and services in long-term care settings, as well as those of the facilities and pharmacies that serve them.”

As independent LTC pharmacies are increasingly important to seniors’ care, medication management and improved outcomes, SCPC released in 2015 a seminal Avalere Health study, “Long-Term Care Pharmacy: The Evolving Marketplace and Emerging Policy Issues,” representing the most detailed analysis of the nation’s growing LTC pharmacy sector since Medicare Part D was implemented in 2006.