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The United States Food and Drug Administration Centers for Medicare & Medicaid Services

The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the... more +
The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the passage of the 1906 Pure Food and Drugs Act. The agency is charged with protecting the integrity of the nation's food supply and cosmetic products, as well as monitoring the safety and efficacy of drugs, medical devices, and biological products.  less -

Capitol Hill Healthcare Update

by BakerHostetler on

The year-end schedules of the Senate HELP and Finance committees just became more clogged, as the two panels will lead the review of President Trump’s nominee to be Health & Human Services (HHS) secretary. Trump announced...more

OIG Wants CMS to Track Medicare Costs from Device Failures

by Reed Smith on

A recent Office of Inspector General (OIG) report suggests that the lack of medical device-specific information on Medicare claim forms complicates CMS efforts to identify and track Medicare costs related to the replacement...more

Under What Circumstances Can a Private Qui Tam Plaintiff Overrule Government Agency Experts' Use of Administrative Discretion to...

• How have appellate courts applied the Supreme Court’s ruling in Escobar? • If the government is aware of the relator’s allegation, but does not undertake any administrative action to address the defendant’s alleged...more

Value-Based Contracting for Prescription Drugs and Medical Devices: An Innovative Solution Impaired by Outdated Regulations

by Pepper Hamilton LLP on

Often lost in the cacophony of headlines surrounding rising health care costs is the promise that value-based contracting offers as a possible solution. In contrast to the traditional fee-for-service model, value-based...more

Capitol Hill Healthcare Update

by BakerHostetler on

With congressional Republicans’ efforts to repeal the Affordable Care Act (ACA) on hold at least for now, the bipartisan leaders of the Senate HELP Committee are seeking to rekindle their work to shore up the health law’s...more

Petratos v. Genentech: Escobar’s “Heightened Materiality Requirement” Is Significant Pleading Hurdle in False Claims Act Suits

In a recent False Act Claims (FCA) suit involving the blockbuster cancer drug Avastin, the Third Circuit barred a relator’s qui tam suit because his Complaint lacked sufficient factual allegations that, if true, would...more

Healthcare Law Update: September 2017

by Holland & Knight LLP on

OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more

Developments in Regenerative Medicine: FDA Announces Plans to Clarify Its Oversight of Cellular Therapy Products and Approves...

by Holland & Knight LLP on

FDA Commissioner Scott Gottlieb, on Aug. 28, 2017, announced steps the agency is taking to begin rolling out policies and guidance documents to clarify its oversight over regenerative medicine products. Dr. Gottlieb...more

Capitol Hill Healthcare Update

by BakerHostetler on

Delayed Senate Health Vote Boon to GOP or Just Prolonging the Inevitable? Senate Majority Leader Mitch McConnell’s announcement that he would delay a key procedural vote scheduled for this week on the Republicans’...more

Capitol Hill Healthcare Update

by BakerHostetler on

Senate Republican leaders are expected to make a series of changes to the healthcare legislation released Thursday as they scramble to gain the support of at least 50 lawmakers in a showdown vote scheduled for later this...more

Measures of success: How value-based pricing may change the pharmaceutical industry

by Hogan Lovells on

Adoption of value-based pricing, where drug prices are linked to real-world outcomes rather than on a per-pill or per-treatment basis, will have a profound impact on the pharmaceutical industry. And with the Centers for...more

Capitol Hill Healthcare Update

by BakerHostetler on

Senate Republicans return to Washington this week after a 10-day recess facing a key inflection point in their effort to repeal and replace the Affordable Care Act (ACA) as GOP leaders will outline policy options they hope...more

Trump Administration FY 2018 Budget and Healthcare Programs

by Holland & Knight LLP on

The Trump Administration released on May 23, 2017, its full Fiscal Year (FY) 2018 budget request, titled "A New Foundation for American Greatness." President Donald Trump's request builds off of the administration's March 16...more

Health Update - May 2017

Mapping the Healthcare M&A Landscape Under the New Administration - Editor’s Note: The healthcare M&A market continues to be among the most active sectors. In a recent webinar, Manatt examined how the policies and goals of...more

Impact of Marijuana on Maine Workers’ Compensation

by PretiFlaherty on

Marijuana use in the State of Maine has been in a state of flux over the past several years. The introduction of the Maine Medical Use of Marijuana Act, Maine Workers’ Compensation Appellate Division decisions, and a recent...more

Capitol Hill Healthcare Update

by BakerHostetler on

House Republicans of all ideological stripes say they are committed to rekindling interest in the American Health Care Act (AHCA), but while the interest is real, so too are the policy and political divisions that thwarted...more

Senate Confirms Verma as CMS Administrator; Trump Nominates Gottlieb for FDA, Hargan as Deputy HHS Secretary

by Reed Smith on

The Senate has approved the nomination of Seema Verma to be CMS Administrator on a vote of 55 to 43. In other nomination news, President Trump has nominated Scott Gottlieb to be Commissioner of Food and Drugs. Dr. Gottlieb is...more

Capitol Hill Healthcare Update

by BakerHostetler on

Trump’s speech: Clarity on ACA next steps? President Trump will address a joint session of Congress on Tuesday, and the expectation is that he will use the primetime moment to outline – at least in broad strokes – his...more

Capitol Hill Healthcare Update

by BakerHostetler on

Meeting privately with Senate Republicans to discuss next steps on the ACA was among the first actions taken last week by the new Secretary of the U.S. Department of Health and Human Services Tom Price. But GOP senators left...more

Capitol Hill Healthcare Update

by BakerHostetler on

Three weeks into President Trump’s administration, the Senate on Friday narrowly approved Tom Price as Secretary of the U.S. Department of Health and Human Services (HHS), elevating the former orthopedic surgeon as Trump’s...more

Blog: Price Confirmed For HHS Secretary, Other Key Agency And Department Positions Next To Be Filled

by Cooley LLP on

Around 2 a.m., the Senate voted along party lines to confirm Representative Tom Price to become Secretary of the Department of Health and Human Services. The vote was 52-47 with no Democrats voting in favor. With repeated...more

Capitol Hill Healthcare Update

by BakerHostetler on

House Speaker Paul Ryan last week set a deadline of the end of March for repealing most of the Affordable Care Act (ACA), as other Republican leaders and conservative rank-and-file lawmakers advocated competing policy...more

A&B Healthcare Week in Review

by Alston & Bird on

On January 9, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers; Draft...more

Capitol Hill Healthcare Update

by BakerHostetler on

At GOP retreat, consensus on healthcare elusive - House and Senate Republicans emerged from a policy retreat last week in Philadelphia with no agreement on next steps in their plan to repeal and replace the Affordable...more

FDA Issues Discussion Paper on LDTs

by King & Spalding on

Following its recent announcement that it would not finalize its 2014 draft guidance on laboratory developed tests (“LDTs”), the U.S. Food and Drug Administration (“FDA”) issued a Discussion Paper on Laboratory Developed...more

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