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Rx Drugs

May 29, 2019 | Daily News

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.

May 29, 2019 | Daily News

FDA’s approval Friday (May 24) of a new drug to treat breast cancer marks the first novel drug that has moved through the agency’s Real-Time Oncology Review (RTOR) Pilot program.

May 29, 2019 | Daily News

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.

May 29, 2019 | Daily News

A new CMS bulletin on spread pricing could pave the way for getting Medicaid managed care plans and pharmacy benefit managers to disclose spread-pricing amounts, according to Alex Shekhdar, founder of Sycamore Creek Healthcare Advisors.

May 24, 2019 | Daily News

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.

May 24, 2019 | Daily News

The dietary supplement industry says FDA should use existing master files to protect the intellectual property of supplement makers, with several industry officials saying such a move would incentivize legitimate companies to continue investing in research.

May 24, 2019 | Daily News

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.

May 24, 2019 | Daily News

FDA’s drug center would receive an approximate $50 million increase in budget authority over fiscal 2019 levels under the 2020 funding bill passed by the House Appropriations agriculture subcommittee on Thursday (May 23), according to a preliminary analysis by the Alliance for a Stronger FDA.

May 23, 2019 | Daily News

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.

May 23, 2019 | Daily News

The House Appropriations agriculture subcommittee on Thursday (May 23) voted to send a fiscal 2020 funding bill that would give FDA a $184 million increase over its fiscal 2019 levels to the full committee.

May 23, 2019 | Daily News

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.

May 23, 2019 | Daily News

A drug industry lawyer and a drug regulation expert applauded a recent FDA draft guidance on the use of real-world evidence (RWE) and real-world data (RWD) in drug and biologics applications as a major step forward, but said questions remain related to data quality and informed consent.

May 23, 2019 | Daily News

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.

May 22, 2019 | Daily News

FDA expects to propose a number of significant new rules over the next year that will address tobacco product applications, warnings for cigarette packages and advertisements, annual reporting requirements for investigational new drugs, and requirements for drug products that are deemed difficult to compound.

May 22, 2019 | Daily News

CMS Administrator Seema Verma on Wednesday (May 22) said the agency is taking its time with a national Medicare coverage policy for new expensive hospital-administered cancer drugs, which was due to be published May 17 but was delayed, because the policy will affect coverage of drugs other than the two chimeric antigen receptor (CAR) T-cell therapies already on the market.

May 22, 2019 | Daily News

Senate Finance Committee Chair Chuck Grassley said Wednesday (May 17) that committee members are considering a rework of financial liability in the catastrophic phase of Medicare Part D to help curb rising drug prices.

May 22, 2019 | Daily News

After legislative talks between House Speaker Nancy Pelosi (D-CA) and President Donald Trump ground to a halt Wednesday morning, Senate Finance Chair Chuck Grassley (R-IA), who is helping lead negotiations on health care policy, said the Senate was always in the driver’s seat in the drug-pricing debate.

May 22, 2019 | Daily News

President Donald Trump said Wednesday (May 22) that legislative negotiations on drug pricing are on hold until Democrats stop investigations into his potential role in his campaign’s ties to Russia and into other actions he has taken while in office.

May 22, 2019 | Daily News

The Trump administration’s spring regulatory agenda, released Wednesday (May 22), shows that two of HHS’ most disruptive drug-pricing regulatory actions -- its proposal to base Medicare Part B pay rates on foreign drug prices and its overhaul of the rebate system -- are set to be released later than originally anticipated.

May 21, 2019 | Daily News

HHS will not publish a rule banning drug rebates before bids from Medicare Part D plans and Medicaid managed care plans are due June 3, according to a memo CMS sent insurers Monday (May 20).

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