Regulatory Authority Actions

Jack Lew, Obama’s secretary of the treasury, announced on April 4, 2016, that the US Department of the Treasury and the Internal Revenue Service (IRS) is issuing temporary and proposed regulations to limit the “benefits of and limit the number of corporate tax inversions.” The government bodies also plan to address earnings stripping in these inversions, so it will examine past inversion deals that have already been completed.

The European Medicines Agency report provides an analysis of the health-technology assessment pilot program, which began in 2010 and completed in March 2016.

The draft guidance states information concerning a clinical study of a biosimilar should only be included if it is necessary to demonstrate the safety and efficacy of the drug.

The campaign against opioid abuse opens door to more innovative therapies.

Cinqair is approved for patients that have a history of severe asthma attacks despite receiving their current asthma medication.

The drug is marketed by Eli Lilly in the US, and will be available at the beginning of the second quarter of 2016.

The draft guidance outlines ways applicants can test for abuse deterrence in solid oral opioid drugs.

The agency announced enhanced warnings for immediate-release opioids to inform prescribers and patients of risks related to use.

Hospira recalls one lot of 8.4% Sodium Bicarbonate Injection, USP, due to particulate matter found within a single-dose glass fliptop vial.

The agency now allows production of water for injection by non-distillation technologies.

The agency cited Emcure Pharmaceuticals with CGMP violations.

Kovaltry is an unmodified, full-length recombinant factor VII product used to treat hemophilia A in adults and children.

The European Medicines Board elects Christa Wirthumer-Hoche as chair of their Management Board.

Both agencies warn of increased rates of serious adverse events, including death, during clinical trials of Zydelig (idelalisib).

Doctors and oncologists agree with pharma companies in opposing the latest proposal from the CMS to revise how it pays for drugs administered in doctors’ offices.

The company recalls one lot of amikacin sulfate injection USP, 1 gram/4mL (250 mg/mL) vials due to the potential presence of glass particulate in one vial.

The group argues that the so-called “incentives” for physicians to prescribe more costly medications are essentially non-existent following a handful of prior cuts to Medicare Part B reimbursement.

Concerns that physicians are not prescribing the most cost-effective medications available have prompted the Centers for Medicare and Medicaid Services to propose a set of new potential reimbursement schemes for Part B drugs in Medicare. CMS says the new proposed rule will test new payment approaches to reward good patient outcomes and will inject value into the system.

Sagent Pharmaceuticals issues a nationwide recall of Fluconazole injection, USP, due to out of specification impurity results.

The agency strengthens its support for treatments of unmet medical needs with launch of new PRIME scheme.

Policy makers debate strategies for promoting access to less costly medicines.

Data integrity is a widespread, global problem that must be addressed.

The program is intended to provide support to ongoing efforts in rare disease product development.

The agency has revised its good pharmacovigilance practices guide on risk management systems.

The agency published guidance on immunogenicity-related considerations for low molecular weight heparin.

The directorate is looking for experts to join the European Pharmacopoeia network.

The course, intended for healthcare professionals, provides an overview of biosimilar products and FDA’s biosimilar product development programs.

The agency is continuing CDER’s Regulatory Project Management Site Tours and Regulatory Interaction Program.

FDA cracks down on makers of products extracted from Cannabis and says the products cannot be considered dietary supplements.

There was scant praise from the medical community for the eighth and final budget plan from the Obama administration.