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California Enacts Bill on Drug Pricing Transparency

by Ropes & Gray LLP on

On October 9, 2017, California Governor Jerry Brown (D) signed into law what may be the most comprehensive prescription drug pricing transparency bill in the country. The bill, SB-17, is intended to foster transparency in...more

New California Law Limits Drug Manufacturer Co-Pay Cards and Other Discounts in California

by Hogan Lovells on

In the most recent salvo by states eager to show an effort to contain prescription drug costs, California's governor has signed into law a bill that will prohibit, with some limited exceptions, pharmaceutical manufacturers...more

OTC Drug Manufacturers: Keep Your Eyes and Ears on Congress

As we previously blogged about in mid-2016, Food and Drug Administration officials have been exploring and pushing for the creation of a new user fee program to support its regulatory activities related to over-the-counter...more

Finding Common Ground in the Healthcare Debate: Federal, State, and Local Governments Respond to the Opioid Epidemic

As stories and statistics of the opioid crisis become increasingly prevalent in our national discourse, we are seeing a stronger, more innovative, and more aligned push for interventions across communities, government...more

Window on Washington - This Week in the Nation's Capital - Vol. 1, Issue 28

by Clark Hill PLC on

White House to Request Emergency Supplemental Funding for Puerto Rico: The White House will submit an additional request to Congress in the next two to four weeks which is not expected to include any deficit restructuring...more

Congress Takes Up FDA Over-The-Counter (OTC) Drug Regulation Reform

by Holland & Knight LLP on

On September 13, the U.S. House of Representatives Energy and Commerce Committee’s Subcommittee on Health held a hearing to examine draft legislation to create a new user fee program and completely revamp the review process...more

Citing the Opioid Abuse Epidemic, New Jersey Proposes Far-Reaching Restrictions on Pharma-Prescriber Interactions

by Stinson Leonard Street on

In an effort to curtail the opioid abuse epidemic, New Jersey Governor Chris Christie proposed a new rule on August 31, 2017 that would make New Jersey the latest state to adopt "gift ban" type restrictions on interactions...more

Congressional Task Force Issues Report on Cybersecurity in the Health Care Industry

by Polsinelli on

Recently, the Health Care Industry Cybersecurity Task Force (the “Task Force”) issued its Report on Improving Cybersecurity in the Health Care Industry (the “Report”). The Task Force, which was created by Congress as part of...more

FDA Takes First Steps to Cut Regulations, Solicits Public Feedback

Since our March 17th post about President Trump’s executive actions aiming to implement his deregulatory agenda, several important developments related to the so-called “2-for-1” Executive Order (E.O. 13,771) have occurred...more

President Trump Signs FDA User Fee Reauthorization Bill into Law – A Relief for the Medical Device Industry

by King & Spalding on

On August 18, 2017, in the nick of time, President Trump signed the FDA User Fee Reauthorization Bill of 2017 (FDARA) (H.R. 2430) into law, bringing a sigh of relief from both FDA and Industry. The law reauthorizes the...more

The Medical Device Tax Lives On

by Knobbe Martens on

For opponents of the 2.3 percent medical device tax, it looked like the repeal/replacement of the Affordable Care Act would alleviate their concerns. However, following the failure of repeal legislation that would have...more

House Passes Bill Relaxing Reporting Requirements

by Knobbe Martens on

The U.S. House of Representatives recently passed the FDA Reauthorization Act of 2017. This bill seeks to change the requirement for companies to report medical device malfunctions to the FDA. Previously, companies had to...more

Senate Passes Long-Awaited FDA User Fee Package

Following nearly two years of negotiations and hearings examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), the Prescription Drug User Fee Act (PDUFA) and the Medical Device User...more

Manatt on Health: August 2017

Next Steps on Healthcare Reform - Though President Trump has continued to call for action on repeal and replace in the wake of the Senate’s failed vote at the end of July, congressional Republicans have been fairly muted...more

Window on Washington - This Week in the Nation's Capital - Vol. 1, Issue 20

by Clark Hill PLC on

McConnell Sets Next Senate Vote for Sept. 5 (The Washington Post). House Set to Bundle 8 Leftover Spending Bills in September: Republicans are set to tackle remaining appropriations bills after returning from August recess,...more

August 2017 Is Here – Will FDARA Get Done Soon?

It has been some time since we provided a detailed update on the status of FDA’s user fee legislation making its way through Congress, so that’s what is on tap for today. The House passed the lengthy FDA Reauthorization Act...more

Baker Administration and Legislature Debate Range of Health Care Proposals

Massachusetts policymakers are currently engaged in a robust debate over several proposals aimed at lowering health care costs in the Commonwealth. The House of Representatives rejected a set of MassHealth reforms that the...more

House Advances Bipartisan FDA User Fee Agreements; Senate Faces Narrow Timeline to Act

by Baker Donelson on

On July 12, the House passed a five-year reauthorization of four different user fee agreements that account for over a quarter of the Food and Drug Administration's (FDA) overall funding. The legislation, titled "The Food and...more

Capitol Hill Healthcare Update

by BakerHostetler on

Congressional Republicans and President Donald Trump face a series of key questions about how or whether to fortify the Affordable Care Act – particularly in the law’s beleaguered individual exchanges – after the Senate last...more

Window on Washington - This Week in the Nation's Capital - Vol. 1, Issue 19

by Clark Hill PLC on

House Passes Spending Bill That Includes Over $1 Billion in Border-Wall Funding: The House passed a $788 billion spending bill that combines a $1.6 billion down payment for President Donald Trump's controversial border wall...more

Trump Administration Policy Statement Calls for FDA Premarketing Activities to be Funded Entirely by Industry Fees

by Knobbe Martens on

The Trump White House released a Statement of Administration Policy on Wednesday in response to the House of Representatives’ passage of H.R. 2430, a bill that would reauthorize the use of four FDA user fee programs: the...more

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

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

Six Questions and Answers About CMS’ Recommended Changes to 340B Medicare Reimbursement

In March, I posted about the Uncertain Future of the 340B Drug Discount Program.  When opining about What Could Happen Next I speculated about possible changes to government reimbursement for 340B drugs “so that government...more

Is Telemedicine Change Coming to Congress? The Medicare Telehealth Parity Act of 2017 Among Several New Federal Bills

by Foley & Lardner LLP on

Congress is reconsidering a nationwide telehealth coverage bill, named the Medicare Telehealth Parity Act of 2017, designed to introduce an incremental, though significant, expansion of coverage for telehealth services under...more

Giving Telemedicine More Room to Breathe: Recent and Pending State and Federal Actions in the World of Online Prescribing

On October 18, 2008, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Haight Act”) came into law as the federal government’s first attempt to address the public health risks associated with online...more

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