Rx Drugs

Days before the House Appropriations Committee is set to mark up an FDA funding bill, an expert on the agency’s budget process said there are plenty of challenges looming ahead that could sink the $184 million increase that House lawmakers propose in the bill.

As FDA weighs how to regulate cannabidiol (CBD) from hemp in food and dietary supplements, the budding industry will hold up a court case from the 1990s to argue that hemp extract with CBD should be allowed in dietary supplements as long as it is not highly concentrated, an industry lawyer said.

Stakeholders are urging FDA to quickly write regulations to strictly monitor the burgeoning cannabis industry, with one marijuana legalization advocacy group warning the lack of guidance and regulation on manufacturing, marketing, testing and selling products infused with cannabidiol (CBD) is creating an opportunity for “predatory companies” to market potentially unsafe products and is leading to confusion about the legal status and safety of CBD-containing products.

If HHS waits until November to ban Medicare drug rebates, consistent with the department’s regulatory agenda, it would be too late to implement the new policy in 2020, sources say.

Maryland on Friday (May 24) became the first state to create a board that will study drug costs, and could be given the power to set drug pay rates. Maryland Gov. Larry Hogan (R) allowed the state legislature’s banner drug-pricing bill to become law without his signature.

The Federal Trade Commission said on Thursday (May 23) that while brand and generic drug makers settled patent disputes more often in fiscal year 2016 than prior years, only one of the agreements met the Supreme Court’s criteria of potentially being anticompetitive.

In a quick turn of events, the focus of drug-pricing legislation in the House shifted from Medicare negotiation to Part D reinsurance reform, which also is the approach that is being considered in the Senate.

FDA has once again officially delayed its planned release of a highly anticipated nonprescription drug proposed rule, although an FDA official said this week the agency hopes to get the rule out as soon as possible.

The Senate health committee’s bipartisan draft bill on lowering health care costs does not expand the Trump administration’s point-of-sale rebate proposal to the commercial market, after Chair Lamar Alexander (R-TN) said the proposal was being considered for inclusion.