PHARMACY

Senate quashes drug importation proposals, draws response from industry groups

BY Jim Frederick

WASHINGTON Bowing to concerns over drug safety and to a deal struck earlier between the Obama administration and U.S. drug makers, the Senate defeated legislation Tuesday that would have opened the way for Americans to directly import pharmaceuticals from Canada and other nations.

A proposal to allow importation, long opposed by the drug industry and retail pharmacy advocates in the United States, failed to win passage by a vote of 51-48, according to reports. The measure needed a 60-vote majority to pass.

The defeat came despite strong backing from some prominent Democrats and Republicans who saw it as a relief measure for seniors hit by rising drug costs and the recession. The Senate also nixed a counter-proposal that would have opened direct importation to medicines certified as safe by the Food and Drug Administration.

The National Association of Chain Drug Stores, an organization representing the nation’s drug stores, said that while it supported the goal of reducing prescription drug costs, it believes importation would put patients’ and consumers’ health and safety at risk, minimize the role of pharmacists in the dispensing of medication and counseling of patients, and adversely disrupt patient care and service.

“The U.S. distribution system is already one of the safest in the world and we are pleased that the Senate acted to preserve the system,” said NACDS president and CEO Steve Anderson. “NACDS has worked to defeat legislation that would compromise the safety of prescription drug distribution channels.”

The trade group Pharmaceutical Research and Manufacturers of America issued a statement Tuesday praising the defeat of both importation proposals. “We continue to support comprehensive healthcare reform so that millions of uninsured Americans can access high-quality and affordable healthcare coverage and services,” said PhRMA SVP Ken Johnson. “We believe that if health reform is done in a smart way, prescription drug importation is not necessary because most Americans will finally have health insurance and access to safe and secure prescription medicines.”

Some consumer advocacy groups, however, sharply criticized lawmakers for failing to allow importation as part of health-reform legislation. AARP EVP Nancy LeaMond expressed the group’s disappointment “that the Senate rejected this smart, bipartisan legislation to help bring down prescription drug prices for millions of Americans.

“For more than 50 years, AARP has been fighting to make health care and prescription drugs more affordable for older Americans,” LeaMond added. “Safe and legal importation is one step toward affordability that we have long supported, and we will continue to work with lawmakers to implement this provision without unnecessary roadblocks.

By contrast, AARP lauded Senate majority leader Harry Reid, D-Nev., and Democratic Sens. Max Baucus of Montana and Chris Dodd of Connecticut for their support Monday of legislation to close the Medicare prescription drug doughnut hole during a House-Senate conference committee on health reform legislation. “AARP sincerely thanks Majority Leader Reid and Sens. Baucus and Dodd for the commitment they made tonight to close the dreaded Medicare doughnut hole, a dangerous gap in prescription drug coverage that leaves more than three million seniors without affordable medications each year,” said AARP CEO A. Barry Rand. “No American should ever be forced to choose between filling their prescriptions or buying their groceries.”

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Ranbaxy will not merge with Nippon Chemiphar

BY Alaric DeArment

GURGAON, India Indian generic drug maker Ranbaxy Labs has dissolved its joint venture with Japan’s Nippon Chemiphar. The dissolution gives Nippon Chemiphar full ownership of the venture, Nihon Pharmaceutical Industry Co.

The two companies had decided that it would serve their respective interests to develop their generic businesses independently, though Ranbaxy will continue to manufacture generic drugs for Nippon Chemiphar at its plants in India.

Japan is the world’s second largest pharmaceutical market and has been gradually opening up to generic drugs. In October, Sandoz launched Japan’s first biosimilar, a follow-on of Pfizer’s human growth hormone Genotropin (somatropin) already marketed in the United States, the European Union and Australia under the name Omnitrope.

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FDA approves generic treatment of Alzheimer’s disease

BY Alaric DeArment

ROCKVILLE, Md. The Food and Drug Administration has approved the first generic version of a drug used to treat dementia related to Alzheimer’s disease, the agency announced Tuesday.

The FDA approved Philadelphia-based Mutual Pharmaceutical’s donepezil hydrochloride orally disintegrating tablets in the 5-mg and 10-mg strengths, a generic version of Eisai’s Aricept. While generic versions of Aricept already are available, the newly approved generic is a version that dissolves on the tongue, designed for patients who have difficulty swallowing.

“Generics offer greater access to health care for all Americans,” FDA Office of Generic Drugs director Gary Buehler said. “Healthcare professionals and consumers can be assured that FDA-approved generic drugs have met the same rigorous standards as the brand-name drug and are the same as the branded in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.”

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