Congress to focus on pandemic prep, FDA policy riders next week

From: POLITICO's Prescription Pulse - Friday Mar 11,2022 05:01 pm

Mar 11, 2022

By David Lim, Lauren Gardner and Katherine Ellen Foley

Presented by the Pharmaceutical Care Management Association (PCMA)

With Rachael Levy

On Tap

— House Democrats are planning to vote next week on standalone legislation to provide new funds for the Covid-19 response after the money was stripped from a larger spending package.

— Senators will mark up bipartisan legislation next week to improve U.S. preparedness for the next pandemic.

— FDA and industry reached a deal this week on the contours of a new medical device user fee agreement.

It’s Friday. Welcome back to Prescription Pulse. We’re not exactly thrilled about the incoming giant Joro spiders, either, but remember: Spiders eat mosquitos, and the enemies of our enemies are our friends.

Send tips, feedback and pics to David Lim (dlim@politico.com or @davidalim), Lauren Gardner (lgardner@politico.com or @Gardner_LM ) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley).

A message from the Pharmaceutical Care Management Association (PCMA):

Over the past half decade, brand pharmaceutical manufacturers have undertaken a massive campaign to deflect blame for their pricing decisions. Ironically, the industry that controls the list price of prescription drugs has attempted to point the finger at those focused on reducing the cost of prescription drugs for patients and payers. We urge Congressional negotiators to continue to resist the latest attempts to shift the blame that puts profits over patients.

Coronavirus

HOUSE PLANS VOTE ON STANDALONE COVID FUNDING NEXT WEEK — The House of Representatives plans to vote next week on a standalone bill containing $15.6 billion of funds the Biden administration argues are critical for an effective Covid-19 response, POLITICO’s Alice Miranda Ollstein reports.

The Covid funds were stripped from the $1.5 trillion omnibus package after several Democrats objected to paying for the aid with money that had been slated to go to their states under a previous Covid relief bill. But the new effort to pass a standalone Covid bill to pay for therapeutics, vaccines and testing must garner Republican votes in the Senate, complicating its path.

The White House warned Thursday that consequences will be severe in the U.S. and abroad if the funding isn’t approved soon.

“We will have to stop a number of components of our program that are essential,” press secretary Jen Psaki told reporters. “If we had that money to move around, we would be moving it. Our assessment is that we need this additional funding in order to meet the needs of the American public.”

PFIZER TO BEGIN KID COVID ANTIVIRAL TRIAL — Pfizer said Wednesday it will kick off a late-stage clinical trial of its Covid-19 antiviral Paxlovid in kids, Katherine reports.

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In Congress

MURRAY, BURR INTRODUCE PANDEMIC PREP BILL AHEAD OF MARKUP — Senate HELP Chair Patty Murray (D-Wash.) and ranking Republican Richard Burr of North Carolina on Wednesday formally introduced their pandemic preparedness legislation ahead of Tuesday’s markup. The 256-page bill builds on a January discussion draft that would require Senate confirmation of the CDC director, aim to improve public health data collection and sharing, and protect against drug and device shortages.

New provisions: The measure now includes sections devoted to bolstering the safety and security of biomedical research and preventing “undue foreign influence” in such work, seemingly flicking at the controversy surrounding so-called gain-of-function research. It also would allow the CDC director to appoint the heads of the various centers within the agency to five-year terms (though with no term limits) and establish an Office of Pandemic Preparedness and Response Policy within the White House.

Heads-up: For ARPA-H watchers, Murray and Burr announced legislation Thursday night to establish the agency within the NIH, a proposal they said they plan to move with the pandemic preparedness bill. Lawmakers proposed funding the new agency this week at $1 billion through the NIH, POLITICO’s Sarah Owermohle reports.

E&C SUBCOMMITTEE SCHEDULES HEARING ON MEDLEY OF FDA BILLS — The House Energy and Commerce Health Subcommittee announced a March 17 hearing on a variety of legislation, including Cures 2.0, ARPA-H and an overhaul of FDA’s accelerated approval program.

CJ Young, a spokesperson for E&C Chair Frank Pallone (D-N.J.), told POLITICO some of the legislation set to be discussed at the hearing could potentially be added to must-pass FDA reauthorization of user fee legislation later this year.

“It’s a possibility, but it’s not like we are fixed on these riding on user fees,” Young said.

LAWMAKERS URGE CMS TO REIN IN DRUG FEES — Sen. Chuck Grassley (R-Iowa) and 29 other lawmakers are calling on the Centers for Medicare and Medicaid Services to finalize a proposed rule about controversial pharmacy fees, Rachael reports.

Pharmacy benefit managers serving patients can demand pharmacies return money to them long after patients pick up their prescription, and the fees can exceed the amount the pharmacy paid for the medicine. These “DIR fees” — short for direct and indirect remuneration — are often based on performance measures, such as patient adherence.

In its proposed rule, CMS says those fees grew more than 107,400 percent between 2010 and 2020. Independent pharmacies have pressed the agency to tackle the charges for years. The rule would bring the fees to point-of-sale, which Grassley et al. say would reduce drug costs for Medicare beneficiaries.

“The meteoric rise of these fees, coupled with the lack of transparency in their application in the [Medicare] Part D program, is contributing to increasing prescription drug costs for patients and the closure of hundreds of pharmacies,” Grassley and the other lawmakers said in a letter to CMS on Monday.

A CMS spokesperson said the agency plans to respond to the lawmakers’ letter.

Eye on FDA

FDA, INDUSTRY REACH MDUFA DEAL — FDA and the medical device industry reached an agreement Monday night on the contours of the fifth iteration of the Medical Device User Fee Amendments.

“We are pleased to share that the FDA and industry have reached an agreement in principle on a framework for MDUFA V,” FDA spokesperson Lauren-Jei McCarthy said in a statement. “As the agency completes additional steps required in this process, we are meeting daily with industry to negotiate the details of the commitment letter, with a goal of publishing the draft agreement for public comment in the near future, followed by the public meeting and delivering the final recommendations to Congress.”

The new five-year deal — which governs user fees the industry pays to FDA to help fund product reviews — contains up to $1.9 billion in total revenue inclusive of potential add-on payments, according to a person close to negotiations.

FDA ORDERS PHILIPS TO PUBLICIZE RECALL — FDA on Thursday took the rare step of ordering Philips Respironics to tell patients, suppliers, distributors, retailers and health care providers about a June 2021 recall of certain ventilators, continuous positive airway pressure and bilevel positive airway pressure machines made by the company. A type of foam in affected products can potentially break down and “be inhaled or swallowed by the person using the device, which can cause irreversible harm to lung tissues, organ impairment and long lasting respiratory dysfunction,” according to FDA.

“The FDA has heard the frustration expressed by patients and durable medical equipment suppliers who are unaware of the recall and have received insufficient information on their next steps regarding the recall process,” FDA Center for Devices and Radiological Health Director Jeff Shuren said.

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Around the Agencies

TSA TO EXTEND FEDERAL MASK MANDATE — The Biden administration will extend its travel mask mandate through April 18 so CDC can craft new guidance for masking on transportation services, POLITICO’s Oriana Pawlyk and Adam Cancryn report.

Tobacco

2.55M KIDS ACTIVELY USED TOBACCO IN 2021, ACCORDING TO FEDERAL STUDY — Newly available data from CDC found that 410,000 middle and high school students regularly smoked cigarettes and 380,000 smoked cigars in 2021, Katherine reports. The data from the agency’s National Youth Tobacco Survey also showed that more than half a million students used products like smokeless tobacco, hookah and heated tobacco products. Nearly 80 percent of those who used tobacco products chose flavored varieties.

Vape dominance: E-cigarettes overwhelmingly dominate youth tobacco use; the same year, more than 2 million middle and high school students regularly vaped.

But remember: Overall tobacco use among kids has gone down since 2019.

FEDERAL TRADE COMMISSION ANNOUNCES MEETING ON E-CIGARETTES — At the virtual meeting on March 17, staff will present a report on e-cig use from 2015 to 2018, with a focus on youth.

LAWMAKERS PRESS FDA TO MAKE DECISIONS ON E-CIGARETTES — Reps. Debbie Wasserman Schultz (D-Fla.) and Diana DeGette (D-Colo.) spearheaded a letter to FDA commissioner Robert Califf on Thursday requesting the agency complete its decisions on e-cigarette products and ban all non-tobacco flavored e-cigarettes. The letter, signed by more than 50 lawmakers, pointed out that it has been more than six months since FDA’s court-ordered deadline to complete pre-market tobacco reviews for e-cigarettes, and unauthorized products remain on the market.

NASEM ISSUES REPORT ON PREMIUM CIGARS — A National Academies of Science, Engineering, and Medicine report published Thursday found that the U.S. imported more than 171 million premium cigars from January to May 2021 — a 73 percent increase from the same time in 2020, suggesting that their popularity is increasing. Still, the cigars make up only a fraction of tobacco use.

A message from the Pharmaceutical Care Management Association (PCMA):

Industry Intel

PHLOW TO BEGIN PROVIDING GENERIC DRUGS TO CHILDREN’S HOSPITALS — Phlow, a Richmond-based pharmaceutical company, announced Wednesday it would be producing its first products this year. It plans to meet the demand of 11 children’s hospitals across the country for four pediatric generic drugs frequently in shortage. Partnering with the drugmaker Fresenius Kabi, Phlow will supply the hospitals with injectable generics: an anti-swelling drug, a steroid, a blood thinner and a drug used as part of the intubation process before surgery.

In 2020, the U.S. federal government issued the company a $354 million contract over four years to use continuous manufacturing to develop generic drugs frequently in shortage — although the four pediatric drugs do not use that technique.

Pharma Moves

Dan Torrens has been named chief executive of eHealth Technologies. He previously was the chief operating officer at ConnectiveRx.

Inozyme Pharma has appointed Sanjay S. Subramanian as senior vice president and chief financial officer and Soojin Kim as senior vice president and chief technical operations officer. Subramanian previously served as CFO and head of corporate development at Ocugen, and Kim was a senior vice president at Hanmi Pharmaceutical.

Inside AgencyIQ

Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA.

FDA revises drug supply chain guidance — FDA released a revised draft guidance document this week to establish expectations for so-called “verification systems” intended to validate that drug products received by manufacturers, repackagers and others are authentic. The systems are related to the Drug Quality and Security Act, a 2013 law which established new anti-counterfeiting measures. Under the law, verification systems are meant to verify authentic products and flag products which are either suspect or illegitimate.

While the guidance revised and expanded some aspects of an earlier version of the guidance released in 2018, some trade groups may be unpleased with some aspects of the new version. The trade group PhRMA had critiqued FDA for asking drug supply chain trading partners to verify product authenticity within 24 hours, calling it potentially infeasible in certain circumstances. That requirement remains in the latest guidance, albeit with a caveat that FDA may excuse companies if there is a disruption beyond their control, such as a natural disaster.

Upcoming FDA advisory committee meeting to assess oncology drugs — FDA’s Oncologic Drugs Advisory Committee (ODAC) will meet next month to review several new and existing products . The meeting comes as oncology drugs have been under an unusually high amount of scrutiny at the agency, generally related to post-marketing trials meant to confirm their safety and efficacy following an accelerated approval. Among the more intriguing questions set to be discussed during the meeting has to do with phosphatidylinositol-3-kinase (PI3K) inhibitors, a drug class used to treat various hematologic malignancies. FDA has asked the committee to consider what the “appropriate” regulatory approach is for the drug class, and “whether randomized data should be required to support” approval.

Document Drawer

House E&C health subcommittee ranking member Brett Guthrie (R-Ky.) introduced legislation this week that would codify FDA’s 2018 guidance outlining permissible communication of pre-clinical trial results with health insurers before FDA approval of a drug or device.

A message from the Pharmaceutical Care Management Association (PCMA):