Content about Pharmaceuticals policy

NEW YORK — The director of the Food and Drug Administration's Office of Generic Drugs is stepping down, according to published reports.

Pharmalot, a blog run by journalist Ed Silverman, reported that Greg Geba is leaving the office over differences resulting from a recent reorganization, effective Friday.

WASHINGTON — Republican and Democratic senators have re-introduced legislation that would ban patent settlements between branded and generic drug companies that critics allege violate antitrust laws, according to published reports.

PALATINE, Ill. — Acura Pharmaceuticals on Tuesday announced that its next-generation pseudoephedrine with abuse-deterrent technology will now be stocked by North Carolina's Kerr Drug. 

Nexafed is a 30 mg immediate-release pseudoephedrine product that combines effective nasal-congestion relief with a unique technology that disrupts the conversion of pseudoephedrine into methamphetamine, Acura noted. 

WASHINGTON — Nearly 98% of primary care physicians, nurse practitioners and pharmacists trust and recommend over-the-counter medicines to their patients, according to a new survey released Wednesday by the Consumer Healthcare Products Association. Nearly three-fourths of primary care physicians recommend OTC medicines to relieve symptoms before recommending a prescription treatment.

ALEXANDRIA, Va. — The National Community Pharmacists Association on Friday submitted written comments urging the Centers for Medicare and Medicaid Services to take action on a wide range of what NCPA characterizes as "anti-patient, anti-pharmacist practices," the association announced. 

WASHINGTON — The Supreme Court will hear arguments later this month in a case that could determine the future of many patent settlements between brand and generic drug makers.

The high court will hear arguments in the case, Federal Trade Commission v. Actavis, on March 25. The case was originally titled FTC v. Watson, but has changed since Watson Pharmaceuticals changed its name following its acquisition of Swiss generic drug maker Actavis.

Canadian generic drug makers expressed dismay over a new plan to reduce reimbursements for a half-dozen generic medications in most of the country's provinces. According to published reports, a group of premiers had reached a coordinated deal to reduce the prices their governments paid for six generic drugs, hoping to save the provinces nearly $100 million.

SILVER SPRING, Md. — The Food and Drug Administration has set user fee rates for generic drug companies, the agency said Jan. 27.

The FDA announced that it had published a notice in the Federal Register for companies that make finished dosage forms, meaning drugs in their final form, and active pharmaceutical ingredients, meaning the main ingredients of the drugs.

Has the explosion in generic utilization curbed pioneer-drug research and development? That's one concern floated by some pharmaceutical industry watchers, who claim that the stunning market share gains made by generic drug makers could reduce incentives for branded drug companies to spend to develop new molecular entities, conduct lengthy clinical trials, gain FDA approval and bring those new drugs to market.

Biosimilar medicines have been approved and routinely prescribed in Europe for nearly seven years, and creation of a clear pathway for Food and Drug Administration review and approval of generic versions of bioengineered drugs was enshrined into law in the United States with the passage of the Patient Protection and Affordable Care Act nearly three years ago. But IMS Health and other industry experts agree it could still be years before biosimilars are available to pharmacies and patients in this country.

Are doctors needlessly raising the costs of America's healthcare system through their prescribing habits? Absolutely, say researchers. A new report appearing in the Jan. 7 issue of JAMA Internal Medicine highlighted the powerful role played by branded drug advertising on consumer preferences and physicians' prescribing habits, and asserted that many doctors ignore the cost-saving benefits of generic drugs when writing prescriptions by acceding to patients' wishes.