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NACDS urges expanded PDUFA provisions
June 14th, 2012
ALEXANDRIA, Va. – The National Association of Chain Drug Stores has called on congressional leaders to expand provisions in the final bill for the Prescription Drug User Fee Act (PDUFA) that would maintain levels of patient care while curbing prescription drug abuse.
NACDS said Wednesday that it has sent letters to Sens. Tom Harkin (D., Iowa) and Michael Enzi (R., Wyo.) of the Senate Health, Education, Labor and Pensions Committee and to Reps. Fred Upton (R., Mich.) and Henry Waxman (D., Calif.) of the House Energy and Commerce Committee to voice its concerns that current PDUFA language falls short of ensuring access to prescription medications for patients who need them for pain management and for the success of their treatment plans.
Language in the current PDUFA bills requires the Food and Drug Administration to review federal initiatives combating prescription drug abuse to identify gaps and opportunities, as well as to issue a report of the findings.
"We believe that to address the problem of prescription drug abuse, rather than just having FDA issue a report, FDA and DEA [Drug Enforcement Administration] must work collaboratively on an ongoing basis. We believe that requiring these agencies to work together would result in better policy solutions, and would greatly help to ensure that legitimate patient access to controlled substance medications is not jeopardized by DEA actions as it is today," NACDS stated in the letters.
NACDS also urged congressional leaders to amend a provision in the Senate's version of PDUFA that would require the Department of Health and Human Services (HHS) to contract with the Institute of Medicine (IOM) on a study of drug abuse to gauge trends and evaluate opportunities to inform and educate the public, patients and health care providers.
In the letters, NACDS recommended that this provision be enhanced beyond these assessments and include work with stakeholders to recommend solutions to the problems of drug diversion and abuse.
"The HHS-IOM process should include a mechanism for panel discussions to include DEA, FDA, patient groups, pharmacy groups, prescriber groups, wholesaler groups, state attorneys general, and law enforcement representatives. Only by inclusion of these key stakeholders can we be assured that the IOM study would provide actionable recommendations that will have a meaningful impact on drug diversion and abuse," NACDS wrote.
"Prescription drug abuse is a complex and immediate problem," the association noted. "To address this problem while ensuring legitimate patient access to prescription medication, I ask for your support in expanding PDUFA legislation so that FDA and DEA will work together, as well as expanding the HHS-IOM process."
PDUFA, enacted in 1992 and renewed several times since then, authorizes the Food and Drug Administration to collect fees from companies that make certain prescription drugs and biological products, including application fees, establishment fees and product fees. According to the FDA, user fees have played a key role in expediting the drug approval process since the enactment of PDUFA.