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Rx Drugs

March 08, 2018 | Daily News

The Senate health committee will hold a hearing on the controversial 340B drug discount program on Thursday (March 15), and while the hearing notice says lawmakers will hear different perspectives on the program, it doesn't specify who will testify.

March 08, 2018 | Daily News

The House Energy & Commerce health subcommittee will hold a two-day legislative hearing on March 21 and 22 to examine more than 20 bills intended to help combat the opioid crisis, the committee announced Thursday (March 8).

March 07, 2018 | Daily News

FDA Commissioner Scott Gottlieb said Wednesday (March 7) that the “rigged” rebate system discourages the development of biosimilars, marking the third straight day of negative press for pharmacy benefit managers.

March 07, 2018 | Daily News

FDA Commissioner Scott Gottlieb said Wednesday (March 7) that the agency is working with HHS Secretary Alex Azar on policies that will help bring more biosimilars to the market, including providing regulatory clarity by integrating policy and review functions; offering tools to help sponsors rely on smaller, targeted trials and develop interchangeable products; countering “misperceptions” about biosimilar safety; and harmonizing development with overseas regulatory partners.

March 07, 2018 | Daily News

Over 50 health care stakeholders recently urged Senate health and House Energy & Commerce committee leaders to include incentives for antibiotic development in the reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA).

March 06, 2018 | Daily News

HHS Secretary Alex Azar and brand drug companies praised UnitedHealthcare for sharing rebates with its customers, and the Pharmaceutical Research and Manufacturers of America says Medicare Part D should adopt the health insurance company’s policy.

March 06, 2018 | Daily News

The White House Office of Management and Budget started reviewing the final Medicare Advantage and Part D rule on Monday (March 5).

March 05, 2018 | Daily News

Nearly all published studies evaluating switching between a biologic and a biosimilar show no differences in immunogenicity, safety or efficacy, according to a newly published literature review from top experts at Sandoz, Novartis and Avalere Health.

March 05, 2018 | Daily News

FDA Commissioner Scott Gottlieb on Thursday (March 1) sent letters to Amazon, eBay, Walmart and Jet asking them to voluntarily stop bulk sales of the anti-diarrheal medicine loperamide -- sold under the brand name Imodium A-D.

March 05, 2018 | Daily News

The Patent Trial and Appeal Board's move late last month to shoot down a closely followed attempt by the Saint Regis Mohawk Tribe to assert sovereign immunity in a bid to keep the Restasis dry eye drug patents it acquired from Allergan out of the inter partes review process has sparked new debate over the board's authority to make such a determination and predictions the issue will ultimately land at the U.S. Supreme Court.

March 02, 2018 | Daily News

A group of 15 Democratic senators, led by Ed Markey (MA) and Sherrod Brown (OH), called on top insurers to revise their existing coverage policies in order to help stem the opioid epidemic.

March 02, 2018 | Daily News

In a Thursday (March 1) memo, Attorney General Jeff Sessions directed the Drug Enforcement Administration (DEA) to consider amending its regulations on manufacturing quotas for schedule I and schedule II substances, including prescription opioids.

March 02, 2018 | Daily News

CMS should more aggressively encourage lock-in programs that would restrict Medicare beneficiaries who are at risk of opioid addiction to a limited number of pharmacies or prescribers, top Republicans and Democrats on the House Ways & Means Committee said in a March 1 letter to CMS Administrator Seema Verma.

March 01, 2018 | Daily News

Sen. Charles Grassley (R-IA) on Tuesday (Feb. 27) introduced legislation to make hospitals report on savings they get from the 340B program, but 340B hospitals say the bill would take savings out of context, and one lobbyist says the legislation could be a stepping stone toward larger 340B reforms.

March 01, 2018 | Daily News

The House Energy & Commerce health subcommittee will focus its next two legislative hearings on opioid bills aimed at enhancing addiction treatment and recovery, as well as legislation dealing with insurance coverage, E&C Committee Chair Greg Walden (R-OR) said during a keynote speech at the Chamber of Commerce’s Combating the Opioid Crisis forum Thursday (March 1).

March 01, 2018 | Daily News

In preparation for writing price-transparency legislation, a bipartisan group of senators is seeking advice on making information on prices for health care services and products available to the public and holding providers and companies accountable for those prices. The lawmakers request feedback from several trade groups, but a press release on the request doesn’t list drug makers or drug-distribution middlemen among the recipients, even though drugs typically are a target of price-transparency proposals.

March 01, 2018 | Daily News

A panel of industry stakeholders and addiction and medicine specialists raised concerns at a House hearing Wednesday (Feb. 28) that research could be stifled and opioid promotion increased under a bill that would amend the Controlled Substances Act to add a sixth scheduling category and another that would mandate 12 hours of opioid prescriber education.

March 01, 2018 | Daily News

FDA announced Thursday (March 1) that it is working with the Department of Justice to block a registered 503B compounder from “manufacturing, processing, packing, labeling, holding and/or distributing” its product after the company disobeyed FDA's wishes and continued compounding after it had to recall all of its sterile products in July 2017.

February 28, 2018 | Daily News

Sponsors of the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act are pushing for the bill to be included in the omnibus spending legislation, which must pass by March 23 to avoid a government shutdown.

February 28, 2018 | Daily News

The Senate health committee voted 22-1 Wednesday (Feb. 28) to advance reauthorization of the Animal Drug and Animal Generic Drug User Fee Amendments to the Senate floor.

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