The National Community Pharmacists Association has submitted recommendations to federal lawmakers as a Senate committee readies legislation to reauthorize the Prescription Drug User Fee Act (PDUFA).


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NCPA gives take on PDUFA reauthorization

April 25th, 2012

ALEXANDRIA, Va. – The National Community Pharmacists Association has submitted recommendations to federal lawmakers as a Senate committee readies legislation to reauthorize the Prescription Drug User Fee Act (PDUFA).

NCPA said it has sent a letter to Sen. Tom Harkin (D., Iowa), chairman of the Senate Health, Labor, Education and Pensions Committee, and Sen. Mike Enzi (R., Wyo.), ranking member on the committee, in response to a "manager's amendment" announced Monday that would revise the legislation. The association's comments focused mainly on prescription drug shortages and pharmaceutical supply chain integrity.

"We believe the current pharmaceutical supply chain in the United States is safe and secure," NCPA chief executive officer B. Douglas Hoey said in a statement. "As we strive to further strengthen security, there are a number of different approaches or tactics that could be employed.

"In addition, while most reported drug shortages to date have occurred in hospital settings, community pharmacies are also experiencing shortages, primarily in drugs that treat ADHD," Hoey added. "The effects of these shortages could be mitigated by reforming the Drug Enforcement Agency's quota system and by ensuring that pharmacy reimbursement rates are updated more frequently to reflect price spikes and keep pharmacies whole."

Regarding shortages of ADHD and other drugs, NCPA noted in the letter that the current DEA quota system is inflexible because it limits the quantity of certain medications that manufacturers can make in any given year. As a result, the association said, Congress should include in any final bill provisions requiring the DEA to "act more favorably and expeditiousl"y on manufacturer requests to increase quotas for certain controlled substances in short supply. NCPA also pointed out that third-party payers, including Medicare Part D and Medicaid, have been slow to raise their reimbursement as costs climb, which compels pharmacies to absorb the increased costs of those medications.

NCPA, too, expressed its support of language in the amendment that would establish voluntary "best practices" for pharmacists regarding the provision of enhanced prescription information to visually impaired and blind individuals.

In the area of supply chain integrity, NCPA gave cost-effective recommendations for track-and-trace proposals, although the PDUFA manager's amendment doesn't include them. The association said it supports the RxTEC proposal, which would create a lot-level tracking program for prescription drugs and require each prescription drug container to have a unique serial number. And in regard to such proposals, NCPA said, Congress should avoid placing burdensome requirements on small community pharmacies, such as requiring them to individually "scan" each product as it enters the pharmacy. Also, NCPA supports the establishment of federal standards for wholesaler licensure.

"In these and other areas," Hoey stated, "we look forward to continuing to work constructively with Congress as a PDUFA reauthorization is enacted into law this year."

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