Three major industry groups are attempting to indefinitely halt FDA's controversial intended use final rule, which they say violates the Administrative Procedure Act, creates a “new and unjustified legal standard” for determining intended use, and could impact public health by limiting scientific discussion about medical products.
The generic drug trade association is the latest group to launch a campaign touting its industry as the solution to lowering drug prices, but it is also using its new campaign to push back against certain drug pricing proposals it sees as bad for the generic market. The Generic Pharmaceutical Association (GPhA) announced Tuesday (Feb. 14) that it will become the Association for Accessible Medicines (AAM) and will launch an advertising campaign both touting generics as a means to increase access to medicines, and opposing drug pricing proposals that would regulate the generic industry in the same way as the brand industry.
As federal and state lawmakers increasingly look to transparency as a way to stem drug price increases, the generic drug trade group has joined with the brand and biotech groups in opposition to a Maryland drug pricing bill, albeit for different reasons. The bill would require both extensive disclosures for any drug with a Wholesale Acquisition Cost of $2,500 or more annually or per course of treatment, as well as notification of expected price hikes. The generic drug industry, which has attempted to cast itself as a solution to drug pricing and has often criticized the brand industry's pricing behaviors, says the bill would unfairly subject generics to the same requirements as branded drugs.
The Trump FDA is moving forward with the agency's plan to revisit how to define "healthy" on food labels by scheduling a public meeting on the issue March 9. Stakeholders also have an extra three months to submit written comments on the issue, until April 26, thanks to a comment extension quietly announced in the final days of the Obama administration.
Congress' investigative arm is calling on the Trump White House to develop a national strategy to coordinate food safety oversight, which now spans across 16 federal agencies and 30 federal laws, saying in a new report that a similar request made six years ago to the Obama White House fell flat. Key Senate Democrats who requested the report wrote to President Donald Trump on Wednesday (Feb. 14) asking him to implement the recommendations.
Marathon Pharmaceuticals is drawing ire from two health policy experts after the company announced it would charge nearly $90,000 for its newly approved corticosteroid to treat Duchenne Muscular Dystrophy. While the price is significantly below the other DMD drug on the market, and for orphan drugs in general, one expert pointed out that the drug has been imported from abroad by patients for years at a fraction of the cost.
Potential abuses of FDA's orphan drug program are facing more scrutiny on Capitol Hill following Marathon Pharmaceuticals' decision to charge nearly $90,000 for its corticosteroid Emfalza (deflazacort) approved by FDA Feb. 9 to treat Duchenne muscular dystrophy (DMD). Former presidential candidate Bernie Sanders (I-VT) and House Oversight ranking Democrat Elijah Cummings (MD) on Monday (Feb. 13) alleged Marathon abused the program, just days after Senate Judiciary Chairman Chuck Grassley (R-IA) announced a more general probe of the orphan drug program.
One industry attorney said it is unclear how HHS and FDA will implement 21st Century Cures language that calls for harmonization of the two regulators' human research subject protection regulations, and she cautioned there will be uncertainty until the issue is worked out. While the attorney argues harmonization is warranted because of the significant burden placed on researchers in trying to resolve the regulatory differences, one consumer advocate told Inside Health Policy that HHS and FDA regulations are already very similar and harmonization was occurring before passage of Cures.
An internal memo from HHS listing department jobs that are exempt from President Donald Trump's federal hiring freeze may bode well for the FDA's newly launched Oncology Center of Excellence (OCE), an initiative aimed at speeding patient access to cancer treatments that is viewed as a model for future creation of other disease-focused centers, according to a cancer research think tank and advocacy group.
A leading consumer advocacy group calling for a ban of certain intravenous (IV) solutions says that an FDA black box warning about risks of the solutions does not go far enough to protect patients, and that FDA's decision to keep the products on the market was based on discredited research that minimized the risks to patients. The group filed a citizen petition Feb. 8 calling for a ban of these products, which it says prevent blood from properly clotting and can cause kidney failure and death. The group has also sent a copy of the petition and a separate letter to the European Medicines Agency urging the European regulator to ban the products.
Top House Energy & Commerce Democrats wrote to the president Wednesday (Feb. 15) asking whether key National Institutes of Health jobs are exempt from the federal hiring freeze, warning the bipartisan 21st Century Cures law and future federal leadership on biomedical leadership could be crippled if critical positions aren't exempted.
The Advanced Medical Technology Association (AdvaMed) has a full-court press underway to convince lawmakers to repeal the Affordable Care Act's medical device tax as part of the upcoming reconciliation bill, identifying the issue as the trade group's number one priority.
Rep. Elijah Cummings (D-MD) and Sen. Bernie Sanders (D-VT) are close to finishing a bill to allow Medicare to negotiate drug prices with drug makers, which they had planned to present to the president in person, but it’s not clear that that meeting will still take place.
Senate Judiciary Chair Charles Grassley (R-IA) said he hopes newly confirmed HHS Secretary Tom Price will be more responsive to lawmakers' concerns than was the Obama administration, particularly around Medicaid drug rebates and misclassifications. He previously said he planned to question CMS chief-nominee Seema Verma about drug pricing at her confirmation hearing, which was held Feb. 16.
Governors are hopeful newly confirmed HHS Secretary Tom Price will let states make successful 1115 Medicaid waivers permanent, simplify 1332 and 1115 waiver processes, and let states collect on some of the federal Medicaid savings accrued when they lower their spending on dual-eligible beneficiaries, a National Governors Association official said.
Drug spending growth slowed from 9 percent in 2015 to 6 percent last year due to a drop in use of hepatitis C drugs, according to 2016 projections that the CMS actuary's office reported Wednesday (Feb. 15).
A key executive from Model N, a cloud-based revenue cycle management company with life science clients, tells Inside Health Policy that he expects rapid policy changes -- such as possible U.S. participation in International Reference Pricing -- under the Trump administration and the drug industry needs to be prepared.
A bipartisan group of three senators, including Senate Finance member Charles Grassley (R-IA), is urging HHS Secretary Tom Price to allow imports of less-costly versions of expensive off-patent prescription drugs that lack competition, but only if the imported drugs are produced abroad by brand companies that invented the drugs or by well-known generic companies that commonly sell drugs in the United States. Price sidestepped questions during a confirmation hearing about whether he would advocate drug imports, a policy pushed by Donald Trump while on the campaign trail.