Generic Line

The high-profile battle over access to emergency contraception ramped up May 1, with the Department of Justice (DOJ) appealing a federal court ruling that would mandate the FDA make TEVA’s Plan B One Step available without age restrictions by May 5.

The Justice Department May 3 filed its second civil false claims suit against Novartis in a week.

The FDA inspected approximately 830 foreign drug manufacturing sites in fiscal 2012, up from 700 in fiscal 2011 and 600 in fiscal 2010.

Deborah Autor, the FDA’s deputy commissioner for global regulatory operations and policy, is joining Mylan’s regulatory policy team.

Sally Howard, chief of staff for HHS Secretary Kathleen Sebelius, has been named the new FDA deputy commissioner for policy, planning and legislation.

House lawmakers April 24 released a draft plan for establishing a national drug track-and-trace system that, in contrast to a Senate plan, lacks an electronic, unit-level pedigree blueprint — an omission reflecting industry angst over the issue.

The Center for Drug Evaluation and Research is considering a reorganization of its functions and adding a strengthened surveillance function as it works to further modernize its approach to pharmaceutical quality, CDER Director Janet Woodcock said late last month.

Sweeping legal reforms in China signal the country’s commitment to improving trade with the U.S., including pressing pharmaceutical industry concerns such as protecting intellectual property rights (IPR) and enhanced enforcement of counterfeiting, a new government report states.

The FDA plans to test a device in Ghana in 2013 and 2014 that it hopes will root out counterfeit and substandard antimalarial drugs.

Drugmakers submitting NDAs or ANDAs containing, or claiming to contain, co-crystals should generate and submit supportive data with their application, according to an FDA final guidance.

In a settlement agreement reached April 26, Purdue Pharma granted Actavis a license to sell a generic version of its abuse-deterrent OxyContin as early as January 1, 2014.

While new proposed rules greatly increase monetary incentives for whistleblowers to expose Medicare and Medicaid fraud, they still fall short of what the False Claims Act already offers.

An appeals court April 26 sided with the FDA in its high-profile fight with AstraZeneca (AZ), saying the agency had every right last year to deny AZ another extension of exclusivity rights for its anti-psychotic Seroquel.

The FDA handed generic drug giant Teva an enforcement letter for making unproven superiority claims and omitting important details about its antipsychotic drug clozapine tablets USP.