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Pharmaceutical Industry › Food and Drug Administration (FDA) › Pending Legislation

Bradley Arant Boult Cummings LLP

MDMA DOA at FDA Advisory Committee

Bradley Arant Boult Cummings LLP on

Avid readers know we have speculated that the legalization of psychedelics as a prescription medicine was “closer than ever.” Unfortunately, for proponents of the legalization of psychedelics like MDMA, progress is rarely a...more

Goodwin

U.S. Senate Passes Significant Drug Pricing Reform in the Inflation Reduction Act of 2022

Goodwin on

​​​​​​​On August 7, 2022, the U.S. Senate passed the Inflation Reduction Act of 2022, which includes some of the most significant drug pricing-related changes since the passage of the Medicare Prescription Drug Improvement...more

Patrick Malone & Associates P.C. | DC Injury...

Congress approves 650-page bill to attack opioid crisis, as doubts abound

Patrick Malone & Associates P.C. | DC Injury... on

Congress has approved a major new push to deal with the opioid crisis that kills tens of thousands of Americans annually. Voters can expect President Trump to sign the big bill, passed easily and with rare bipartisan support...more

Sheppard Mullin Richter & Hampton LLP

In a Unanimous Vote, the Opioid Crisis Response Act of 2018 Makes it Onto the Legislative Calendar

Sheppard Mullin Richter & Hampton LLP on

As previously discussed in our post from September 2017, the push for a response to the opioid crisis is gaining momentum. Enter the “Opioid Crisis Response Act of 2018.” On May 7, 2018, the Opioid Crisis Response Act of...more

Goodwin

Congress Mulls Passage of CREATES Act

Goodwin on

The CREATES Act (Creating and Restoring Equal Access to Equivalent Samples Act), currently pending in Congress states as its aim to promote drug price competition by removing an impediment to the development and approval of...more

Goodwin

White House Releases Policy Statement Calling For Elimination Of Federal Funding For FDA’s Pre-Market Review Costs

Goodwin on

The White House released a statement of administration policy on July 12 in response to the House of Representatives passing H.R. 2430, a bill that would reauthorize the FDA’s user fee programs, including FDA’s biosimilar...more

Patrick Malone & Associates P.C. | DC Injury...

Don’t give medical device makers more time before disclosing product woes

Patrick Malone & Associates P.C. | DC Injury... on

Pro-business and anti-consumer lawmakers in Congress are racing to slacken rules for medical device makers to report problems with their products. This move may imperil more patients, many of whom already have been harmed...more

Goodwin

Appeal for Legislative Action to Address REMS Concerns

Goodwin on

Last month, during the Biosimilar and Generics User Fee Acts (BsUFA II and GDUFA II) reauthorization hearing, a subject of considerable discussion was Risk Evaluation and Mitigation Strategies (REMS). REMS is a provision...more

Patrick Malone & Associates P.C. | DC Injury...

Congress weighs approval for sweeping, $6.3 billion 21st Century Cures Act

Patrick Malone & Associates P.C. | DC Injury... on

It’s almost 1,000 pages, culminates at least three years of work, and provides a $6.3 billion boost for an array of health-related agencies and initiatives. Will the U.S. Senate join the House in bipartisan passage of the...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: House Energy and Commerce Subcommittee Holds Hearing on Legislation to Strengthen Medicaid Program Integrity and Fraud Controls... Bipartisan Senate Bill Introduced to Stop Anti-Competitive “Pay-For-Delay”...more

Mintz - ML Strategies

Health Care Update - August 2015 #2

Mintz - ML Strategies on

Major Medicaid Drug Payment Rule Under OMB Review: Last week a highly anticipated rule that could set the standards for the Medicaid Drug Rebate program arrived at the White House for final review. The Medicaid Outpatient...more

Arnall Golden Gregory LLP

Arnall Golden Gregory Series Explains Provisions in the 21st Century Cures Act

Arnall Golden Gregory LLP on

On July 10, 2015, the House of Representatives passed the 21st Century Cures Act by a vote of 344-77. The bill is intended to promote drug and device development, support research and expedite patients’ access to new...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: House Ways & Means Committee Holds Markup; Makes Significant Legislative Changes to Health Care Bills... Senate Finance Committee Holds Markup on Medicare Appeals Process Bill... CMS Issues Final Rule on...more

BakerHostetler

21st Century Cures Act Passes House Committee

BakerHostetler on

The House Energy and Commerce Committee unanimously approved H.R. 6, the “21st Century Cures Act,” on May 21, 2015, after reaching a bipartisan agreement to fund the legislation (Cures bill). Often described as a “landmark...more

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