Regulatory and Washington

SILVER SPRING, Md. — Food and Drug Administration commissioner Dr. Scott Gottlieb has taken to the agency’s FDA Voice blog to outline the efforts he’s undertaking that are aimed at increasing competition in the generics market. The FDA’s Drug Competition Action Plan begins with a public hearing on July 18 to assess the places where FDA regulations could be creating obstacles to generic access.

ARLINGTON, Va. – The Food and Drug Administration last week announced that this fall, as part of a comprehensive approach to the regulation of digital health tools, the agency will pilot an entirely new approach toward regulating this technology. The announcement was welcomed by industry.

WASHINGTON — Senate majority leader Mitch McConnell on Thursday unveils the body’s much-anticipated answer to the Affordable Care Act. The Better Care Reconciliation Act is a 142-page bill that largely mirrors the American Health Care Act that passed the House of Representatives last month, with some key differences.

WASHINGTON — Two lawmakers recently introduced legislation that aims to make compounded medications more accessible to patients. Reps. Morgan Griffith, R-Va., and Henry Cuellar, D-Texas, introduced HR 2871, the Preserving Patient Access to Compounded Medications Act of 2017.

The act would clarify the Drug Quality and Security Act in a way that would align the statute with congressional intent to balance the issues of public safety and patient access. The bill’s introduction has been praised by pharmacy organizations.

SILVER SPRING, Md. — The Food and Drug Administration last week approved Adamis Pharmaceuticals’ Symjepi, a pre-filled dose syringe of epinephrine. The syringe is indicated for emergency treatment of allergic reactions, including anaphylaxis.

EAST WINDSOR, N.J. — Aurobindo Pharma USA on Monday announced that its had received Food and Drug Administration approval for its generic of Genzyme’s Renvela (sevelamer carbonate for oral suspension).

The drug is indicated for the control of serum phosphorus in patients with chronic kidney disease.

Aurobindo’s generic will be available in 08.- and 2.4-g pouches. The drug had a market size of $139.9 million for the 12 months ended April 2017, according to QuintilesIMS data.

WASHINGTON — To combat teen abuse of over-the-counter medicines containing the cough suppressant dextromethorphan, Oregon Governor Kate Brown on Thursday signed legislation prohibiting the sale of DXM-containing products to minors.

The move makes Oregon the 14th state to pass an age-18 sales law, joining states across the country in recognizing that limiting teen access to DXM is a proven way to prevent abuse, according to the Consumer Healthcare Products Association.

ALEXANDRIA, Va. — As the Trump administration reviews policies in the Medicaid managed care rule, the National Community Pharmacists Association shared with Seema Verma, administrator of the Centers for Medicare and Medicaid Services, a list of provisions it hopes will be included in the rule.