News & Analysis as of

Healthcare Orphan Drugs

Manatt, Phelps & Phillips, LLP

A Focal Point for FDA’s Rare Diseases Efforts: CDER’s New ARC Program

Last week, the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) launched a new program to coordinate and centralize CDER’s rare disease activities. The mission of the Accelerating Rare...more

Hogan Lovells

FDA’s Bendeka decision reverses approvals of Treanda generics

Hogan Lovells on

Wednesday, FDA released a letter stating how the agency intends to implement the scope of orphan drug exclusivity awarded to Eagle Pharmaceuticals’ Bendeka (bendamustine HCl) by the D.C. Circuit Court in Eagle...more

Mintz - ML Strategies

Health Care Update - October 2015

Mintz - ML Strategies on

Senate Working Group Pressing Forward on Telehealth - As Congress focuses on bigger picture policy decisions, including broad budget negotiations and raising the debt ceiling, there are some exciting developments on the...more

BakerHostetler

D.C. District Court Deals Blow to HHS 340B Program Interpretive Rule

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Court says Congress has the power to make the change that HHS attempted with its Interpretive Rule, and thus it should be left to the legislative branch. A lawsuit challenging the Interpretive Rule, filed by the...more

Troutman Pepper

District Court Rules Pharmaceutical Manufacturers Are Not Required to Discount Orphan Drugs - Regardless of the Condition Being...

Troutman Pepper on

HHS’ rule requiring pharmaceutical manufacturers to discount orphan drugs when they were used to treat non-rare diseases was inconsistent with Congress’ intent to exclude all orphan drugs from the 340B discount program for...more

Polsinelli

Orphan Drug Ruling Disrupts the 340B Program

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On Wednesday, the United States District Court for the District of Columbia issued its highly anticipated opinion regarding the 340B orphan drug litigation. The Court ruled in favor of PhRMA, a trade association that...more

King & Spalding

HRSA Publishes Proposed 340B Drug Pricing Program Omnibus Guidance - Comments Due to HRSA on or before Tuesday, October 27, 2015

King & Spalding on

On Friday, August 28, 2015, the Health Resources and Services Administration (“HRSA” or “the Agency”) published in the Federal Register Notice of its proposed “omnibus” or “mega” guidance (“Proposed Guidance”) regarding...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: Senate Reauthorizes Older Americans Act; Bill Heads to the House... White House Holds 2015 Conference on Aging and Launches Several New Administration Healthy Aging Initiatives Enveloping Alzheimer’s, Dementia,...more

K&L Gates LLP

340B Update: HRSA Proposes Penalties for Drug Manufacturers that Overcharge Covered Entities

K&L Gates LLP on

On June 16, 2015, the U.S. Department of Health and Human Services (“HHS”) and the Health Resources and Services Administration (“HRSA”) released proposed rules on civil monetary penalties and drug ceiling prices under the...more

Mintz - Health Care Viewpoints

The Increasingly Murky World of 340B: What’s Next?

For the past 18 months, health care providers and the pharmaceutical industry have been hoping for some clarity regarding 340B Drug Discount Program operations. But things just keep getting murkier....more

King & Spalding

HHS Issues Interpretive Rule Excluding Orphan Drugs from 340B Program Discounts Only for Designated Orphan Status Uses

King & Spalding on

On July 21, 2014, the Health Resources and Services Administration of HHS (HRSA) issued an interpretive rule interpreting Section 340B(e) of the Public Health Service Act as excluding from the 340B Drug Pricing Program orphan...more

Faegre Drinker Biddle & Reath LLP

HHS Relabels Invalidated 340b Regulation As “Interpretative Rule”

Earlier this week HHS came out swinging in the latest round of its battle with the Pharmaceutical Research & Manufacturers of America (PhRMA) over the Affordable Care Act’s provisions on 340B and orphan drugs. HHS reasserted...more

BakerHostetler

The Orphan Drug Wars: HHS’s Rebuttal to Its Recent Loss to PhRMA

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On June 18, 2014, the U.S. Department of Health and Human Services (HHS) publicly stated that the recent decision of the U.S. District Court for the District of Columbia to vacate HHS’s regulation covering orphan drugs and...more

Faegre Drinker Biddle & Reath LLP

HHS Poised For Round Two Of Orphan Drug Fight

HHS isn’t ready to throw in the towel in the fight over expansion of the 340B program under the Affordable Care Act (ACA). On Thursday HHS said in a court filing that it will appeal last month’s federal court ruling that...more

BakerHostetler

The Orphan Drug Wars: HHS’s Recent Loss to PhRMA

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On May 27, 2014, almost a year following the promulgation of its final rule, the U.S. Department of Health and Human Services (HHS) had its rule vacated by the U.S. District Court for the District of Columbia under an...more

Mintz - Health Care Viewpoints

’Orphan drug’ rule raises off-label worries for drugmakers

The U.S. Department of Health and Human Services last week clarified when hospitals are allowed to buy socalled orphan drugs at sharply discounted prices, but it left open questions for drug manufacturers about the risk of...more

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