VICP, Colorado PDAB, and AMR

This week is off to a busy start, with the House introducing bills to strengthen the Vaccine Injury Compensation Program, Colorado’s PDAB taking action, and an important discussion on AMR and amputees. (834 words, 4 minutes, 10 seconds)

House introduces bills to strengthen Vaccine Injury Compensation Program

Two bipartisan bills to strengthen the Vaccine Injury Compensation Program (VICP) were introduced in the U.S. House Friday under the leadership of Rep. Lloyd Doggett (D-TX).

Why it matters: Strong VICP protections help build confidence in vaccines.

The Vaccine Injury Compensation Modernization Act, introduced with Rep. Lloyd Smucker (R-PA), would reduce the time Health and Human Services (HHS) has to add a vaccine to the VICP injury table (from two years to six months) while ensuring the table covers immunizations routinely recommended for adults by the CDC. The bill would also increase the number of special masters, the appointed judges overseeing these claims, to decrease the backlog of existing cases.

The Vaccine Access Improvement Act, co-led by Rep. Mike Kelly (R-PA), would impose the 75-cent excise tax that funds VICP on any new immunizations added to the injury table, eliminating the need for Congress to act separately.

What they’re saying: “Those who suffer rare injuries associated with vaccines, including those to fight COVID-19, should receive prompt, reasonable compensation,” Doggett told POLITICO. “By assuring a prompt and fair response to any related injury, we build confidence in vaccines and reduce hesitancy.”

BIO’s view: “The Vaccine Injury Compensation Program has long been important for patients, providing appropriate compensation for those who may have been injured by a routine immunization,” said BIO’s Phyllis Arthur, SVP of Infectious Diseases & Emerging Science Policy. “BIO applauds Reps. Doggett, Smucker, and Kelly for their commitment to strengthening this program that is a vital part of our nation’s public health and immunization infrastructure. We look forward to working with them and the Senate sponsors who included similar provisions in their bipartisan PAHPA reauthorization legislation.”

Colorado PDAB votes to conduct affordability review

The Colorado Prescription Drug Affordability Board (PDAB) voted Friday to conduct an affordability review on a small group of medicines.

Why it matters: While seven states (CO, MD, ME, MN, NH, OR, & WA) have PDABs, Colorado is the first in the country to begin conducting affordability reviews that potentially lead to price controls on therapies.

BIO and the Colorado BioScience Association (CBSA) submitted joint testimony to the PDAB, noting the “flawed list of recommended products…places a disproportionate emphasis on innovative products for the treatment of rare diseases.” BIO and CBSA urged the PDAB to correct “critical errors” in the list before conducting a review.

BIO’s take: “We have serious concerns with the quality of the selection process and the flawed foundation it has set for this review,” said BIO’s Chief Advocacy Officer Nick Shipley, expressing disappointment. “We are also deeply concerned with the disregard the PDAB showed for the patients who spoke up, urging the board not to rush forward with untested price controls on rare disease medicines. This decision sets a terrible precedent for patients and will lead to less access to medicines for people across Colorado.” 

The next steps: Colorado’s PDAB is scheduled to meet again in October.

Why AMR matters to amputees

Antimicrobial resistance (AMR) has special implications for patients with limb loss and limb difference, BIO’s AMR expert Emily Wheeler said Friday at the Amputee Coalition 2023 National Conference.

Why AMR matters: Pathogens are evolving to develop immunity to our existing stock of antimicrobials. An estimated 1.3 million people worldwide die each year directly because of AMR, and nearly 5 million fatalities were linked to AMR in 2019.

Why AMR matters to amputees: “AMR directly impacts the limb loss and limb difference community through health challenges like wound care and sepsis,” says Wheeler, BIO’s Director of Infectious Disease Policy. “Additionally, an amputation itself can both be caused by a resistant infection or can sometimes, unfortunately, result in a drug-resistant infection.” Jean Mwale, also on the panel, is a sepsis survivor, advocate for the limb loss community, and an Amputee Coalition regional ambassador. Jean developed a septic shock infection so severe that it resulted in bilateral below-the-knee amputation and the amputation of four fingertips on one of her hands as she explains in this interview with CBS.

Can’t we develop new antimicrobials? The market is broken, says everyone from BIO to the London School of Economics and Nature. Antibiotic stewardship requires these drugs to be used sparingly, making development “risky and relatively unprofitable.”

One possible solution:The PASTEUR Act, proposed legislation in which the government would “pay for consistent access to novel antimicrobials with payments that are decoupled from the volume of antimicrobials used,” Wheeler has explained.

Patients and patient groups can help, by giving a voice to the problem and telling Congress of the importance of passing PASTEUR, she told the panel.

The bottom line: “Superbugs will always persist—surviving pathogens will continue to evolve into antimicrobial-resistant strains. But if we leverage the policy solutions at our disposal to fix the broken ecosystem for antimicrobial development—including advancing PASTEUR—we can be prepared to fight them,” says Wheeler.

More Health News: 

New York Times: For the first time, there’s a pill for postpartum depression
“The Food and Drug Administration on Friday approved the first pill for postpartum depression, a milestone considered likely to increase recognition and treatment of a debilitating condition that afflicts about a half-million women in the United States every year.”

President Biden’s Monday: Hosting World Series champs the Houston Astros at the White House. Later, traveling to the Grand Canyon, where he’s expected to declare a national monument, which would prevent uranium mining on the site, per The Washington Post.

What's Happening on Capitol Hill: The House and Senate are in recess through Labor Day.