Generics

NEW YORK — Drug makers may be allowed to seek approval for a generic version of an eye drug made by Allergan based on lab tests rather than clinical trials, according to published reports.

In a draft guidance released Friday, the FDA said that due to the efficacy profile of Allergan's drug for dry eyes Restasis (cyclosporine) ophthalmic emulsion, it wouldn't be effective for companies to conduct clinical trials to determine the efficacy of a generic version.

WASHINGTON — Generic drug makers cannot be held liable if patients suffer harmful side effects after taking their drugs, the Supreme Court has ruled in a 5-4 decision.

WASHINGTON — A White House trade policy leader has been appointed as U.S. trade representative.

The Senate voted last week to approve Michael Froman to the position. Froman was previously an adviser to President Barack Obama on international economic affairs and replaces acting U.S. Trade Representative Miriam Sapiro.

MONMOUTH JUNCTION, N.J. — Tris Pharma has hired a former buyer from AmerisourceBergen to head its generic drug business, the company said.

Tris announced the appointment of Janet Penner as president of the new generic pharmaceuticals business, which will have its own sales, marketing and distribution and will be responsible for bringing drugs to market. So far, the Food and Drug Administration has approved 13 of Tris' generics, including several first-to-market products.

SPRINGFIELD, Ill. – Pharmaceutical wholesaler H.D. Smith will buy a majority interest in a Cincinnati-based patient assistance, pharmaceutical brand support and reimbursement company.

The wholesaler said Thursday that it had originally acquired majority board representation in Triplefin and would secure majority stock ownership in it. Financial terms of the deal were not disclosed.

ROCHESTER, Minn. — A large majority of Americans are taking prescription drugs, according to a new study by the Mayo Clinic.

The study, published online in the journal Mayo Clinic Proceedings, found that nearly 70% of Americans are taking at least one drug, and more than half are taking two. Most of the drugs are antibiotics, antidepressants and opioid painkillers. Researchers said the data, which came from the Rochester Epidemiology Project, would be valuable because it would give insight into prescribing practices.

PARSIPPANY, N.J. — More responsible use of drugs could save the U.S. healthcare system more than $200 billion per year, according to a new study by the research arm of IMS Health.

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.