HealthCare Roundtable e-News – December 2, 2021

Lawmakers Unveil Cures 2.0, Aim to Fast-Track in House

As the year comes to a close, competing legislative priorities, including Democrats’ $1.75 trillion reconciliation package, are likely to hold up review of any additional bills throughout the rest of 2021. According to Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.), their recently unveiled Cures 2.0 legislation may not make it to the floor before year’s end due to delays in the bipartisan bill’s initial release.

Cures 2.0, a bill aimed at revolutionizing how the U.S. provides care to patients by speeding up the delivery of new cures, treatments, and innovations. The legislation would also require Medicare to cover breakthrough medical devices faster and make permanent key flexibilities to telehealth reimbursement for providers. Some of the provisions call for some significant FDA reforms and could be linked to FDA’s fiscal 2023 user fee agreements, which Congress needs to reauthorize by September 2022, despite DeGette and Upton’s preference for moving the bill separately while user fee bills take an extended amount of time getting through Congress.

Upton and DeGette had previously stated that they wanted to get Cures 2.0 passed by the end of the year so that ARPA-H could be up and running as soon as possible. However, both lawmakers admitted last week that the initial deadline might not be feasible unless they put in “some long nights.” Upton stated that he and DeGette would rather fast-track passage of Cures while there are several provisions in the bill that would need to be implemented quickly. (InsideHealthPolicy)

House Reps Express Bipartisan Interest in Linking Drug Exclusivity Periods to Value

House lawmakers are looking to collaborate on legislation that would link drug exclusivity periods to the value of the drug to society. Both Reps. Jodey Arrington (R-TX) and Scott Peters (D-Calif.) have expressed interest in the idea, which would extend the exclusivity period of products like those that treat previously untreatable conditions over other products that don’t have the same value.

Arrington, who opposed Medicare drug price negotiation as included in the Democrats’ $1.75 reconciliation package, has said before that he would prefer to introduce generic and biosimilar competition sooner and to get other countries to pay more for drugs. 

“I don’t believe we should have a one-size-fits-all exclusivity path, which is a monopoly, for all products and all-size markets and all profit margins,” Arrington said during an event organized by the Council for Affordable Health Coverage. (InsideHealthPolicy)

Rep. Peters, who supported exploring the idea, had previously led the movement to scale back Medicare drug price negotiation in the Democrats’ package, suggesting the concept would be worth exploring if instead of conditioning prices based on value, the government would condition exclusivity on value. Now, it’s unclear whether there will be additional talks around drug pricing reforms since House Democrats have passed the scaled-back Medicare price negotiation deal in the reconciliation package. (InsideHealthPolicy)

Pfizer, Moderna Reach Agreements with Orgs Enabling Increased Global Access to COVID-19 Pills and Vaccines

Vaccine manufacturers Pfizer and Moderna have both recently brokered deals with the U.S. government and global non-profits to share licenses and patents around each’s COVID-19 protection products, including Pfizer’s coronavirus pills and Moderna’s coronavirus vaccine patents. The agreements are aimed at increasing global protection of the virus, particularly those countries that have lower vaccination rates and/or access to protective medicines. 

According to an announcement last week (Nov. 16), Pfizer signed a licensing pact with the Medicines Patent Pool to let 95 low- and middle-income countries make the company’s oral antiviral for COVID-19 Paxlovid once the FDA authorizes the drug for emergency use. The agreement is aimed at reaching countries with average per capita incomes of less than $2,600, emphasizing that Pfizer would not receive royalties from the drug sold in low-income countries and would waive royalties on sales in middle-income countries until after the pandemic. (InsideHealthPolicy)

“This license is so important because, if authorized or approved, this oral drug is particularly well-suited for low- and middle-income countries and could play a critical role in saving lives, contributing to global efforts to fight the current pandemic,” MPP Executive Director Charles Gore said.

Moderna, who has been involved in several disputes over ownership over who deserves credit for inventing the central component of its COVID vaccine, recently came to an agreement with the National Institutes of Health by offering the organization co-ownership of the patent. According to the drug maker, the company will allow the Biden administration to “license the patents as they see fit.”

Woodcock Discourages Proposals to Create New FDA Centers of Excellence

Acting FDA chief Janet Woodcock recently raised concerns about efforts to create new centers of excellence at the agency, arguing that the development would create some organizational complications and require additional resources that the agency does not currently have access to. Woodcock added that the agency has been critically under-staffed and financially constrained throughout the pandemic, which has added complications.

Several lawmakers have expressed interest in building new centers of excellence to support key disease areas, including Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.), who proposed setting up two new centers, one of which would focus on rare diseases and the other on neuroscience, in their Cures 2.0 legislation. However, Woodcock emphasized in her Biopharma Congress interview last week that now is not the time to set up new structures within the agency.

“If you go too far down that road, there’s nothing wrong with that, but you’d have to reorganize all the medical products centers differently, if you’re going to have all these clinical groups by clinical indication rather than by product type or whatever commodity,” Woodcock said. (InsideHealthPolicy)

In the interview, Woodcock was also asked whether she thought making FDA an independent agency could help remove some of those barriers. The acting chief responded by stating that she doesn’t know whether the resource issue is linked to FDA’s place in the hierarchy at HHS. (InsideHealthPolicy)