Regulatory and Washington

ROCKVILLE, Md. — A backlog of more than 2,000 drug entities and devices is awaiting approval. That’s the situation facing the Food and Drug Administration and the generic pharmaceutical industry—and it’s the chief impetus behind the FDA’s push to impose user fees on generic drug makers seeking the agency’s review and approval for their brand-equivalent medicines.

ALEXANDRIA, Va. — The natural affinity that has sprung up between independent pharmacy and the generic drug industry — both viewed as underdogs in the relentless fight for market position and profits: one versus powerful chain and big-box retailers, the other versus the far more entrenched and well-funded branded drug industry — was never more fully realized than it was at the end of October, when the National Community Pharmacists Association introduced its new top manager to its members at the group’s annual meeting.

CAMBRIDGE, Mass. — Poor medication adherence is one of the nation’s “most persistent” healthcare problems, costing the U.S. health system as much as $290 billion a year, or 13% of total health expenditures, according to the New England Healthcare Institute. In response, the nonprofit organization is calling for an urgent national campaign to improve adherence through a team-based, collaborative approach to long-term patient therapy.

NEW YORK — A ghost from 2008 soon could come back to haunt 2010.

According to published reports, the Food and Drug Administration may be considering adopting tougher standards for certain classes of generic drugs if it determines that some are not equivalent to their branded counterparts.

WASHINGTON — A panel of healthcare thought leaders has concluded that a recent IRS rule change going into effect Jan. 14, 2011, will demand retail system challenges that are operationally impossible to overcome in the limited time frame required.

And the National Association of Chain Drug Stores couldn’t agree more.

ALEXANDRIA, Va. — In a ruling hailed by retail pharmacy leaders, the Department of Defense now is insisting that drug manufacturers extend the same discounts for prescription drugs sold at community pharmacies that the military gets for medicines dispensed through base dispensaries or mail order.

WHAT IT MEANS AND WHY IT’S IMPORTANT — There’s been quite an uproar following healthcare reform’s flexible spending account proposal that in January will force consumers to spend upward of $40 on doctor visit co-pays in order to save some $2.50 for every $10 spent on nonprescription items.

WHAT IT MEANS AND WHY IT'S IMPORTANT — Retail pharmacies scored a big victory in the Centers for Medicare and Medicaid Services rule, which puts the kibosh on pricing policies that would have severely affected retail pharmacies' ability to make money from generic drugs, and thus forced them to turn away Medicaid patients.