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FDA Week - 02/17/2017

  • PhRMA, BIO, MIWG File Petition To Block FDA's Intended Use Rule

    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.

    965 words

  • GPhA Becomes 'Association For Accessible Medicines,' Launches Campaign

    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. The Generic Pharmaceutical Association (GPhA) announced Tuesday (Feb. 14) that it will become the Association for Accessible Medicines (AAM) and will launch an advertising campaign both touting generics as a means to increase access to medicines, and opposing drug pricing proposals that would regulate the generic industry in the same way as the brand industry.

    1255 words

  • Generic Drug Group Joins BIO, PhRMA To Oppose Maryland Pricing Bill

    As federal and state lawmakers increasingly look to transparency as a way to stem drug price increases, the generic drug trade group has joined with the brand and biotech groups in opposition to a Maryland drug pricing bill, albeit for different reasons. The bill would require both extensive disclosures for any drug with a Wholesale Acquisition Cost of $2,500 or more annually or per course of treatment, as well as notification of expected price hikes. The generic drug industry, which has attempted to cast itself as a solution to drug pricing and has often criticized the brand industry's pricing behaviors, says the bill would unfairly subject generics to the same requirements as branded drugs.

    1725 words

  • FDA Moves On Plan To Rethink 'Healthy' On Food Labels With March Meeting

    The Trump FDA is moving forward with the agency's plan to revisit how to define "healthy" on food labels by scheduling a public meeting on the issue March 9. Stakeholders also have an extra three months to submit written comments on the issue, until April 26, thanks to a comment extension quietly announced in the final days of the Obama administration.

    817 words

  • GAO To Trump: Coordinate Food Oversight Split Among 16 Agencies

    Congress' investigative arm is calling on the Trump White House to develop a national strategy to coordinate food safety oversight, which now spans across 16 federal agencies and 30 federal laws, saying in a new report that a similar request made six years ago to the Obama White House fell flat. Key Senate Democrats who requested the report wrote to President Donald Trump on Wednesday (Feb. 14) asking him to implement the recommendations.

    1644 words

  • As Grassley Probes Orphan Drug Program, Price of Duchenne Drug Draws Ire

    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. While the price is significantly below the other DMD drug on the market, and for orphan drugs in general, one expert pointed out that the drug has been imported from abroad by patients for years at a fraction of the cost.

    1267 words

  • Lawmakers Allege Orphan Drug Program Abuses Following DMD Price Hike

    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 (DMD). Former presidential candidate Bernie Sanders (I-VT) and House Oversight ranking Democrat Elijah Cummings (MD) on Monday (Feb. 13) alleged Marathon abused the program, just days after Senate Judiciary Chairman Chuck Grassley (R-IA) announced a more general probe of the orphan drug program.

    794 words

  • Attorney: Uncertainty Looms On Cures 'Common Rule' Implementation

    One industry attorney said it is unclear how HHS and FDA will implement 21st Century Cures language that calls for harmonization of the two regulators' human research subject protection regulations, and she cautioned there will be uncertainty until the issue is worked out. While the attorney argues harmonization is warranted because of the significant burden placed on researchers in trying to resolve the regulatory differences, one consumer advocate told Inside Health Policy that HHS and FDA regulations are already very similar and harmonization was occurring before passage of Cures.

    1513 words

  • Advocacy Group Hopeful Oncology Center Exempt From Hiring Freeze

    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.

    1621 words

  • Public Citizen Pushes FDA To Go Beyond Black Box Warning on IV Solutions

    A leading consumer advocacy group calling for a ban of certain intravenous (IV) solutions says that an FDA black box warning about risks of the solutions does not go far enough to protect patients, and that FDA's decision to keep the products on the market was based on discredited research that minimized the risks to patients. The group filed a citizen petition Feb. 8 calling for a ban of these products, which it says prevent blood from properly clotting and can cause kidney failure and death. The group has also sent a copy of the petition and a separate letter to the European Medicines Agency urging the European regulator to ban the products.

    1100 words

  • House E&C Dems Ask Trump How Hiring Freeze Affects NIH, Warn 'Cures' Law At Stake

    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.

    423 words

  • AdvaMed Lobbies For Repeal Of Medical Device Tax In 1st Reconciliation Bill

    The Advanced Medical Technology Association (AdvaMed) has a full-court press underway to convince lawmakers to repeal the Affordable Care Act's medical device tax as part of the upcoming reconciliation bill, identifying the issue as the trade group's number one priority.

    676 words

  • Cummings, Sanders Close To Finishing Drug-Price Negotiation Bill

    Rep. Elijah Cummings (D-MD) and Sen. Bernie Sanders (D-VT) are close to finishing a bill to allow Medicare to negotiate drug prices with drug makers, which they had planned to present to the president in person, but it’s not clear that that meeting will still take place.

    213 words

  • Grassley Hopes Price Responds To Congress On Medicaid Rebates

    Senate Judiciary Chair Charles Grassley (R-IA) said he hopes newly confirmed HHS Secretary Tom Price will be more responsive to lawmakers' concerns than was the Obama administration, particularly around Medicaid drug rebates and misclassifications. He previously said he planned to question CMS chief-nominee Seema Verma about drug pricing at her confirmation hearing, which was held Feb. 16.

    486 words

  • NGA To Price: Simplify 1115, 1332 Waivers

    Governors are hopeful newly confirmed HHS Secretary Tom Price will let states make successful 1115 Medicaid waivers permanent, simplify 1332 and 1115 waiver processes, and let states collect on some of the federal Medicaid savings accrued when they lower their spending on dual-eligible beneficiaries, a National Governors Association official said.

    392 words

  • Rx-Spending Growth Slows But Remains One Of The Fastest Growing Sectors

    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).

    635 words

  • Reference Pricing Eyed By Some As Rx Pricing Answer

    A key executive from Model N, a cloud-based revenue cycle management company with life science clients, tells Inside Health Policy that he expects rapid policy changes -- such as possible U.S. participation in International Reference Pricing -- under the Trump administration and the drug industry needs to be prepared.

    1647 words

  • Senate Trio Asks Price To Allow Drug Imports In Limited Circumstances

    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 sell drugs in the United States. Price sidestepped questions during a confirmation hearing about whether he would advocate drug imports, a policy pushed by Donald Trump while on the campaign trail.

    507 words

  • HHS Spokesperson: Zika Liability Shield 'Declaration' Not Subject To Reg Freeze

    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.

    430 words

  • Democrats: Trump 2-1 E.O. Ignores Regulatory Benefits, Only Counts Costs

    Key Senate Democrats are calling on President Donald Trump to explain why benefits of regulation are not being considered in his two-for-one executive order aimed at scaling back regulations.

    703 words