January 8, 2021|
The U.S. Food and Drug Administration had a busy 2020, as detailed in earlier blog posts. This blog post explores politics and a few policy activities we’ll be keeping an eye on in 2021 and how they might impact medical product manufacturers, particularly now that we know the U.S. Senate will be controlled, like the U.S. House of Representatives and the White House, by Democrats.
November 23, 2020|
With the presidential transition underway, we now look forward to what the Biden administration will seek to accomplish, particularly in the realm of health care policy.
September 16, 2019|
This week, Congress is working towards passage of a continuing resolution that would fund the government through the middle of November. This will give policymakers and appropriators enough time to hash out differences in funding priorities as well as work on policies addressing drug pricing, surprise billing, and funding for public health programs. The surprise billing issue is really heating up with outside stakeholder groups weighing in and Congress carefully considering its next steps
July 30, 2019|
Senators Chuck Grassley (R-IA) and Ron Wyden (D-OR), Chairman and Ranking Member (respectively) of the Senate Finance Committee, have fired the latest shot in Congress’s ongoing battle against high drug prices. Last week, the Senators introduced their much-anticipated proposal to lower drug prices: a chairman’s mark called the Prescription Drug Pricing Reduction Act (PDPRA) of 2019.
July 29, 2019|
This week, the Senate is expected to vote on a budget deal that would also suspend the debt limit for two years. This clears a major hurdle come September when both chambers of Congress will be in session with a laundry list of policies and programs to address, including appropriations.
This week, the House is set to vote on repeal of the Cadillac tax, which is a forty-percent tax on high-cost health plans established by the Affordable Care Act. While its prospects for passage in the Senate are not entirely clear, passage out of the House clears an important hurdle. In other news, we are continuing to monitor the evolving drug pricing debate which is still expected to ramp up in the coming weeks with action from the Administration and Senate.
This week, the Affordable Care Act (ACA) is back in the news with oral arguments set to begin before the U.S. Court of Appeals for the Fifth Circuit. The court will decide whether to uphold a federal district court's ruling that struck down the ACA. This case has the potential to reshape the political landscape in 2020 if it reaches the Supreme Court. On Capitol Hill, policymakers are working hard to bring forth a drug pricing package before the August recess
This week, the House is poised to take action on drug pricing by passing two pieces of legislation. As the House moves the bills through final passage, focus will shift to the Senate, which will unveil a legislative package around lowering costs for consumers in the coming weeks. The scope of this package is still unclear, but it should include a number of proposals that could pass on a bipartisan basis. We cover this and more in this week's preview, which you can find by clicking here.
April 26, 2019|
Following the two week recess, Congress is back in session and will have several high profile hearings this week. For starters, the Energy & Commerce Health subcommittee will continue reviewing prescription drug costs, this time focusing in on Medicare. In the Rules Committee, which does not typically host high profile hearings, they will hold the first committee hearing on H.R. 1384, one of the "Medicare for All" proposals.
April 8, 2019|
This week, Congress will continue to look at lowering health costs. The House has been focused on both drug costs and overall health care costs, advancing packages to strengthen the individual market in addition to a series of bipartisan drug pricing bills.
March 7, 2019|
In our first two Device Modernization series posts, we discussed FDA’s 510(k) modernization efforts and the proposed De Novo regulation. FDA has also had a heavy hand in legislative efforts to retool oversight of laboratory developed tests (LDTs) and other in vitro diagnostics (IVDs). The proposed approach would create an entirely new category of medical product separate from medical devices known as in vitro clinical tests (IVCTs).
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