Enact PDUFA, but leave restrictions out of it

With overwhelming support in both the U.S. House and Senate and the strong backing of President Obama, a reauthorization of the landmark Prescription Drug User Fee Act that funds new drug application reviews at the Food and Drug Administration is a near certainty, probably within days or weeks at most. But one amendment to the Senate's version of PDUFA reauthorization, contained in the Food and Drug Administration Safety Innovation Act, could threaten both retail pharmacies and the patients they serve.

That amendment, from Sen. Joe Manchin, D-W.Va., was slipped in as the Senate hammered out its final version of the Safety Innovation Act. It has nothing to do with the reauthorization of user fees, which are paid each year by drug manufacturers to help the FDA allay the staffing and operational costs of reviewing the hundreds of new drug applications it receives each year.

Instead, Manchin decided PDUFA would serve as a handy legislative vessel in which he could insert new and unnecessary restrictions on the sale of pain remedies commonly available in any pharmacy.

The Manchin proposal would make it tougher for patients to obtain common pain relief remedies containing hydrocodone — and tougher by far for pharmacies to offer them. How? By raising those pain relief meds from Schedule III to the more-restrictive Schedule II classification.

The nation's top community pharmacy advocates haven't let the amendment go unchallenged. Five pharmacy groups — the American Pharmacists Association, Food Marketing Institute, International Academy of Compounding Pharmacists, National Association of Chain Drug Stores and National Community Pharmacists Association — sent a letter in late May to every U.S. member of Congress and senator, warning that the new classification would "result in significant barriers for patients who have a legitimate need for these products and result in adding to the nation’s health care costs with no assurance of a reduction in diversion and abuse."

The restrictions would also make it impossible for doctors to phone prescriptions into pharmacies for those pain relievers, or even to electronically prescribe them in some states. What's more, if enacted, the shift to Schedule II would boost dispensing costs to pharmacies, noted the organizations, "including significantly higher administrative costs, due to recordkeeping, inventory management and storage requirements."

If you agree, join NACDS and other groups in opposing the Manchin amendment. If not, please share your reasons why with us.