Regulatory and Washington

WASHINGTON — One of the more recognizable faces of the Natural Products Association, VP global government and scientific affairs Daniel Fabricant, will be leaving association work in favor of the Food and Drug Administration, Drug Store News learned Wednesday.

A staunch advocate of natural products who has testified before Congress on behalf of the supplement industry, Fabricant will join the FDA as director of the division of dietary supplement programs by the end of February.

ALEXANDRIA, Va. — An amendment to remove certain reporting requirements from the 1099 business tax form is winning praise from the retail pharmacy chain lobby.

The National Association of Chain Drug Stores announced Wednesday its support for an amendment introduced by Sen. Debbie Stabenow, D-Mich., that would repeal an expansion of reporting requirements that it said would burden businesses, including retail pharmacies, with thousands of additional tax forms.

NEW YORK — Fears about the likelihood of medication errors have officials in Pennsylvania mulling the possibility of restrictions on patients transferring prescriptions from one pharmacy to another, according to published reports.

CNBC reported Sunday that a rule recently put in place by the Ohio Board of Pharmacy that allows only one transfer per year had inspired Pennsylvania officials to consider a similar rule for their own state.

MENLO PARK, Calif. — Optivia Biotechnology on Tuesday announced that the company and the Food and Drug Administration have signed a collaboration agreement to assess the effect of dietary supplements on key drug transporters.

Drug transporters are proteins on the surface of cells that either facilitate or hinder the transport of nutrients or pharmaceuticals. Drug transporters can increase or decrease the absorption of drugs into the body, as well as limit or facilitate the exposure of certain organs.

Years 2009 and 2010 were up and down for the generic drug industry and its main trade group, the Generic Pharmaceutical Association. On one hand, there were the departures of president and CEO Kathleen Jaeger and member company Teva Pharmaceutical Industries.

BASEL, Switzerland — The Food and Drug Administration has approved a Novartis vaccine for preventing meningococcal disease in children, the Swiss drug maker said.

Novartis announced the approval of Menveo (meningococcal [groups A, C, Y and W-135] oligosaccharide diphtheria CRM197 conjugate vaccine) for active immunization to prevent certain forms of meningococcal disease caused by Neisseria meningitidis in children ages 2 to 10 years. The FDA approved the vaccine last year for use in adolescents and adults ages 11 to 55 years.

SAN DIEGO — The Food and Drug Administration has turned down an application for an anti-obesity drug.

Orexigen Therapeutics and Takeda Pharmaceutical said Tuesday that the FDA had issued a complete response letter for their application for Contrave (naltrexone hydrochloride and bupropion hydrochloride) extended-release tablets.

As soon as members of Congress took their seats last month, the new Republican majority announced it would make good on its pledge to repeal the Patient Protection and Affordable Care Act. The effort largely is symbolic and unlikely to succeed, so at least one portion of the healthcare-reform law will likely remain in effect, namely the abbreviated approval pathway for follow-on biologics, also known as the Biologics Price Competition and Innovation Act.