Content about Pharmaceuticals policy

The generic drug tidal wave became a tsunami in 2012, with some of the world's top-selling pharmaceuticals swamped by generic competition, and health plan payers scrambling to reap billions of dollars in financial savings.

Behind every prescription that lands at the pharmacy counter is a series of events that influence the prescriber’s decision. Powered by data from SDI Health, Drug Store News goes inside the examination room in this exclusive report, providing an in-depth look at the critical factors that shape pharmaceutical sales trends and shift market share from one drug to another in 10 key market segments.

Click below to download the complete PDF of the 2011 Annual Prescriber Report.

NEW YORK — The Food and Drug Administration's Center for Drug Evaluation and Research has collected 84% of the fees it intends to collect this year under a law passed last year to collect user fees from generic drug members, according to a memo sent out to CDER staff Tuesday.

CDER director Janet Woodcock wrote that the FDA had collected more than $255 million under the Generic Drug User Fee Amendments to the 2012 Prescription Drug User Fee Act reauthorization. The agency plans to collect $299 million in fiscal year 2013.

NEW YORK — Patent settlements between brand and generic drug makers commonly referred to as "pay-for-delay" settlements are not necessarily against the law, the Supreme Court ruled Monday.

PORT WASHINGTON, N.Y. — Aceto Corp. will sell an authorized generic version of a drug used to treat a rare but devastating degenerative disorder.

Aceto said it would launch the authorized generic version of Covis Pharma's Rilutek (riluzole) tablets in the 50-mg strength through its Rising Pharmaceuticals subsidiary. The drug is used to treat amyotrophic lateral sclerosis, also known as Lou Gehrig's disease.

Sales of the drug were about $64 million in 2012, according to Aceto.

LEXINGTON, Mass. — Drug maker Amag Pharmaceuticals has licensed the U.S. commercial rights to a treatment for a common side effect of cancer treatments from another company, Amag said Monday.

Amag said it licensed the rights for MuGard, used to treat oral mucositis, a condition that affects about 400,000 cancer patients each year. The drug is an oral mucoadhesive that works by creating a gel coating over the oral mucosa to shield the membranes of the mouth and tongue.

SEOUL, South Korea — South Korean drug maker Hanmi Pharmaceutical Co. and U.S. partner Amneal Pharmaceuticals have made an agreement in federal court concerning a generic heartburn drug that they said clears a major hurdle to its launch.

WASHINGTON — The House of Representatives voted Monday to pass a bill that would establish national standards for the pharmaceutical supply chain.

PORT WASHINGTON, N.Y. — A subsidiary of Aceto Corp. has launched a generic treatment for seasonal and perennial allergies, the company said Tuesday.

Rising Pharmaceuticals announced the launch of flunisolide nasal solution in the 0.025% strength.

SAN ANTONIO — Retail pharmacists will be missing out on as much as a $20 billion opportunity if they don't identify how to consistently and efficiently engage their patients, suggested Jeff Rehling, principal at Edgewood Consulting Group, during a business session Sunday at the recent 2013 GMDC Health & Wellness @Retail Conference. 

When does the double-edged sword of generic drug price reductions begin to cut the government agency or health system holding the sword?

That's the question many pharmacy leaders in Canada have for the provincial health system policy-makers who have embarked on a crusade to whack pharmacy reimbursement levels for many lower-cost generic medicines sold under the nation's publicly funded health system. The effort has drawn the ire of pharmacy advocates even as proponents in government and health policy circles tout its cost-saving benefits.

The year is only halfway done, but 2013 is already proving to be a year of particular importance for generic drugs as the industry awaits two important decisions from the Supreme Court and continues to wait for federal biosimilar regulations while fending off efforts to limit the scope of their use at the state level.