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Rx Drugs

June 13, 2019 | Daily News

FDA’s decision to center its compounding regulatory program in the drug center’s compliance office represents a shift to a more enforcement-focused approach to compounding, according to a drug compounding lawyer.

June 13, 2019 | Daily News

FDA on Wednesday (June 12) issued a call for stakeholders to send pathogen samples to the agency in order to help build a database to support the rapid identification of infectious diseases in patients.

June 13, 2019 | Daily News

As part of their investigation into the dangers of illicit fentanyl, much of which comes from China, a bipartisan group of House Energy & Commerce Committee leaders wrote to FDA Acting Commissioner Ned Sharpless and heads of five other federal agencies to request briefings on the effect the opioid epidemic is having on public health and on their solutions for stopping the flow of illicit fentanyl into the United States.

June 11, 2019 | Daily News

Florida GOP Gov. Ron DeSantis on Tuesday (June 11) signed the state legislature’s bill that orders Florida to create a Canadian prescription drug importation program. Florida is the third state to pass such a law, and the first to enact one law passed by a Republican-dominated legislature.

June 11, 2019 | Daily News

White House budget officials began reviewing Tuesday (June 11) HHS’ final version of a rule to ban drug rebates in Medicare and Medicaid that aren’t shared at the point of sale.

June 10, 2019 | Daily News

FDA hopes to encourage more diversity in clinical trials through draft guidance that lays out how drug and biologic sponsors can broaden eligibility criteria, avoid unnecessary exclusions and reduce burdens on trial participants.

June 07, 2019 | Daily News

Connecticut lawmakers’ effort to pass a sweeping health reform bill collapsed in the state’s senate late Wednesday (June 5), the final day of the session.

June 07, 2019 | Daily News

Opioid maker Insys Therapeutics, which manufacturers fentanyl product Subsys, will plead guilty to five counts of mail fraud, pay millions in fines and pay to settle allegations that it violated the False Claims Act, the Department of Justice (DOJ) announced Wednesday (June 5).

June 07, 2019 | Daily News

Lawyers in the gene therapy field said FDA’s approval of AveXis’ Zolgensma, a new drug for treating spinal muscular atrophy (SMA), lays the groundwork for an expected wave of future gene therapy drug applications.

June 07, 2019 | Daily News

The Biosimilars Forum is scheduled to meet with White House budget officials June 10 to discuss policies that the trade group says would reduce Medicare spending by boosting the use of biosimilars, according to the Office of Management and Budget website.

June 07, 2019 | Daily News

Washington is the fourth state to seek approval from CMS to enter performance-based contracts with drug makers, according to documents obtained by Inside Drug Pricing.

June 07, 2019 | Daily News

CMS Administrator Seema Verma on Thursday (June 6) called out large hospital systems for anti-competitive behavior, and said CMS policies like pay cuts for 340B drugs and site-neutral pay policies -- both of which led to lawsuits over CMS’ authority to enact them -- were put in place to help combat consolidation and physician movement from independent work to hospital employment.

June 06, 2019 | Daily News

Lobbyists for brand drug makers have told Senate Finance Committee staff they’re open to paying a share of seniors’ catastrophic Medicare Part D drug costs in exchange for capping seniors’ out-of-pocket costs and relieving drug makers of the 70% discounts they currently must pay for drugs that beneficiaries take while in the donut hole, according to sources close to the negotiations.

June 06, 2019 | Daily News

As all eyes are on Oklahoma’s trial against drug maker Johnson & Johnson over its role in the opioid epidemic, the number of states filing charges against opioid makers is stacking up.

June 06, 2019 | Daily News

FDA on Monday (June 3) announced a pilot program call center at its oncology office that is meant to serve as an information hub for physicians treating patients with cancer who seek access to unapproved therapies.

June 06, 2019 | Daily News

Just days after FDA held a 10-hour meeting to discuss the science and regulation of cannabis-based products, Americans for Safe Access issued a resource guide for patients, health care providers, consumers and anyone interested in learning more about cannabidiol (CBD).

June 06, 2019 | Daily News

In the absence of federal regulations and amid a patchwork of state regulations for cannabis products, epilepsy patients are using unapproved cannabidiol (CBD) without any clear direction on dosage or any knowledge of what is in their products, stakeholders told FDA at a public meeting Friday (May 31).

June 05, 2019 | Daily News

The bipartisan National Governors Association wants the federal government to let states import drugs and exclude Medicaid coverage of fast-tracked, first-in-class drugs while additional tests are done on them.

June 05, 2019 | Daily News

Proposals to reform the 340B program were excluded from three legislative packages to cut health care cost that have either been recently introduced or publicly disclosed, and Sen. Bill Cassidy (R-LA), an author of 340B legislation, said that’s because Democrats are not on board.

June 05, 2019 | Daily News

Senate Finance Chair Chuck Grassley (R-IA) said Wednesday (June 5) that he wants drug makers to take on a share of costs in the catastrophic phase of Medicare Part D, and health insurance plans to also pay more.

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