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Rx Drugs

Friday, 17 February 2017

Sen. Tom Cotton (R-AR) announced in a Feb. 16 floor speech that he will craft a legislative solution to price hikes associated with the orphan drug program, following news of an expected increase in the cost of a newly approved drug to treat Duchenne muscular dystrophy.

Friday, 17 February 2017

CMS Administrator-nominee Seema Verma said Thursday (Feb. 16) that she does not support giving vouchers for Medicare beneficiaries to buy insurance, she supports extending funding for the Children’s Health Insurance Plan for eight years, she’ll help Congress investigate EpiPen Medicaid rebates and she’ll make innovation center demonstrations voluntary.

Wednesday, 15 February 2017

Drug spending growth slowed from 9 percent in 2015 to 6 percent last year due to a drop in use of hepatitis C drugs, according to 2016 projections that the CMS actuary's office reported Wednesday (Feb. 15).

Wednesday, 15 February 2017

Top House Energy & Commerce Democrats wrote to the president Wednesday (Feb. 15) asking whether key National Institutes of Health jobs are exempt from the federal hiring freeze, warning the bipartisan 21st Century Cures law and future federal leadership on biomedical leadership could be crippled if critical positions aren't exempted.

Tuesday, 14 February 2017

The generic drug trade association is the latest group to launch a campaign touting its industry as the solution to lowering drug prices, but it is also using its new campaign to push back against certain drug pricing proposals it sees as bad for the generic market.

Tuesday, 14 February 2017

A bipartisan group of three senators, including Senate Finance member Charles Grassley (R-IA), is urging HHS Secretary Tom Price to allow imports of less-costly versions of expensive off-patent prescription drugs that lack competition, but only if the imported drugs are produced abroad by brand companies that invented the drugs or by well-known generic companies that commonly sells drugs in the United States.

Monday, 13 February 2017

Potential abuses of FDA's orphan drug program are facing more scrutiny on Capitol Hill following Marathon Pharmaceuticals' decision to charge nearly $90,000 for its corticosteroid Emfalza (deflazacort) approved by FDA Feb. 9 to treat Duchenne muscular dystrophy.

Monday, 13 February 2017

An internal memo from HHS listing department jobs that are exempt from President Donald Trump's federal hiring freeze may bode well for the FDA's newly launched Oncology Center of Excellence (OCE), an initiative aimed at speeding patient access to cancer treatments that is viewed as a model for future creation of other disease-focused centers, according to a cancer research think tank and advocacy group.

Friday, 10 February 2017

Three major industry groups are attempting to indefinitely halt FDA's controversial intended use final rule, which they say violates the Administrative Procedure Act, creates a “new and unjustified legal standard” for determining intended use, and could impact public health by limiting scientific discussion about medical products.

Friday, 10 February 2017

Marathon Pharmaceuticals is drawing ire from two health policy experts after the company announced it would charge nearly $90,000 for its newly approved corticosteroid to treat Duchenne Muscular Dystrophy.

Friday, 10 February 2017

A newly released HHS declaration creating a Zika vaccine liability shield does not violate President Donald Trump's regulatory freeze, an HHS spokesperson told Inside Health Policy.

Friday, 10 February 2017

Drug developers now have clear details on when they should conduct abuse-related studies during drug development thanks to FDA's final guidance detailing best practices for evaluating when a new drug has potential to be abused, industry experts say.

Thursday, 09 February 2017

FDA approved Thursday (Feb. 9) Marathon Pharmaceuticals' Emflaza (deflazacort), the first corticosteroid approved in the United States to treat Duchenne muscular dystrophy (DMD).

Thursday, 09 February 2017

HHS personnel slots listed as exempt from President Donald Trump's federal hiring freeze appear to apply to some FDA drug center generic drug user fee hires, according to an internal HHS memo and an FDA drug center list of job opportunities.

Thursday, 09 February 2017

As attention turns to drug distribution middlemen in the debate over rising drug prices, pharmacy benefit managers have launched another coalition, and the industry’s trade group rolled out a series of new videos in its campaign to emphasize the work that pharmacy benefit managers do to lower drug prices.

Thursday, 09 February 2017

The court of appeals for the Federal Circuit on Wednesday (Feb. 8) suspended an injunction in a patent dispute that would have pulled one of the two biologics in a new category of cholesterol medications from the market.

Wednesday, 08 February 2017

A group of 31 senators led by Judiciary Committee ranking Democrat Patrick Leahy (VT) is asking Kaléo Pharmaceuticals to justify the price hike of its opioid reversal product, a naloxone auto injector called Evzio, from $690 in 2014 to a current wholesale acquisition cost (WAC) of over $4,000.

Tuesday, 07 February 2017

White House Press Secretary Sean Spicer said Tuesday (Feb. 7) that the president wants Medicare to negotiate drug prices in the way that other countries keep down their drug spending.

Tuesday, 07 February 2017

Vice President Mike Pence met with Right to Try advocates Tuesday (Feb. 7), bolstering the hopes of the Goldwater Institute that Congress will move on legislation, which, if enacted would shield pharmaceutical companies and prescribers from liability if they provide experimental drugs to terminally ill patients under state Right to Try systems.

Monday, 06 February 2017

House Energy & Commerce Chairman Greg Walden (R-OR)'s now-stalled plan to mark up this week a new bill that would create a generic priority review voucher program as a solution to drug pricing is seen by a Democratic health care lobbyist as an orchestrated attempt by the brand industry and E&C Republicans to avoid drug pricing measures being attached to upcoming user fee reauthorizations.

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