Taking a breather from the political rhetoric that’s permeated the U.S response to COVID-19 and pushed legislation aimed at lowering drug prices to the back burner, a House subcommittee Wednesday advanced several bipartisan bills intended to improve the safety and ensure the supply of drugs and medical devices.

The novel coronavirus was mentioned a few times as part of the impetus for some of the bills before the Energy and Commerce Subcommittee on Health. For instance, both Democrats and Republicans cited the outbreak in their support of H.R. 4866, the National Centers of Excellence (NCE) in Continuous Pharmaceutical Manufacturing Act, which would appropriate $80 million annually from fiscal 2021 to 2025 to establish NCEs to work with the FDA and industry to craft a national framework to implement continuous manufacturing.

The funding also would support additional R&D of the technology, workforce development, standardization, and collaboration with manufacturers in the adoption of continuous manufacturing. The intent of the legislation is to encourage advanced manufacturing in the U.S., reducing the dependence on foreign sources for active pharmaceutical ingredients and finished drugs, said Rep. Frank Pallone (D-N.J.), one of the sponsors of the bill. COVID-19 has revealed the risks of having so much of the drug supply manufactured in other countries, he added.

Subcommittee Chair Anna Eshoo (D-Calif.) described continuous manufacturing as “the pathway to bring drug manufacturing back to the United States.” She said the technology is key to addressing concerns about subpar manufacturing of drugs, tainted drugs and shortages.

Rep. Brett Guthrie (R-Ky.), another sponsor of H.R. 4866, agreed, saying, “This bill is crucial.”

Another bill forwarded to the full committee responds to safety concerns about imported medical devices. H.R. 5663, the Safeguarding Therapeutics Act, would give the FDA the authority to destroy certain imported medical devices that are adulterated, misbranded or unapproved that may pose a threat to public health. Although the agency currently has that authority with drugs, it has to return to the sender imported noncompliant devices – even if they contain drugs that could otherwise be destroyed, Guthrie noted.

“Counterfeit medical devices are a growing medical threat,” said Rep. Eliot Engel, referencing the joint action the FDA and Indian authorities recently took that stopped about 500 shipments of potentially dangerous, unapproved medical products from entering the country. The threat has grown with the outbreak of COVID-19, Engel added, as some companies are falsely marketing products to protect against or treat infections caused by the virus.

Closing loopholes

Other health-related bills the subcommittee sent to the full Energy and Commerce Committee would close loopholes and address gaps in the FDA’s regulatory authority. H.R. 4712, the Fairness in Orphan Drug Exclusivity Act, would close a loophole that enables drug companies to game orphan drug exclusivities to prevent competition.

Currently, drugs are granted seven years of orphan exclusivity if sponsors have no reasonable expectation of recovering the costs they incurred in developing and marketing the therapies in the U.S. for a rare disease or condition. Even if the drug becomes profitable, it retains the exclusivity. But to keep the exclusivity under H.R. 4712, sponsors would have to demonstrate each year of the seven-year period that they still have no expectation of recovering their costs.

As part of that annual demonstration, the bill directs the FDA and manufacturer to take into consideration the sales of all the manufacturer’s drugs for the rare disease or condition, as well as all its drugs containing the same active molecular components.

Companies have been taking advantage of the orphan exclusivity even when they’ve been making a profit, said Rep. Buddy Carter (R-Ga.), a sponsor of the bill. That has hurt competition and public health, he noted, as was the case when the manufacturer of a drug used to treat opioid dependence was able to delay competitors because of its orphan exclusivity.

Rep. Ann Kuster (D-N.H.) said, “This issue has dire implications on access to treatments for opioid disorder.”

If H.R. 4712 becomes law, companies with drugs already granted orphan exclusivity will be required to do the annual demonstrations for the duration of their exclusivities. If they can’t demonstrate the drug is not profitable, they will lose the exclusivity. Rep. Michael Burgess (R-Texas) expressed some concern about the retroactive application of the bill, telling his colleagues that the inclusion of such a provision in H.R. 4712 shouldn’t be seen as a precedent for other bills; otherwise it would instill uncertainty throughout the legislative system.

Closing another gap, H.R. 5668, the MODERN Labeling Act, would give the FDA the authority to require modifications of outdated labeling for generic drugs. The bill lays out a path for those labeling changes that will be initiated by the agency. Once notified of a required change, the generic manufacturer will have 30 days to respond.

Since generic labels have to follow that of the brand drug, generic labeling can get frozen in time when the brand withdraws from the market, even though new safety evidence may emerge. The FDA tried to address that problem when it issued a proposed rule in 2013 that would have allowed generics, like their brand counterparts, to independently update their labeling with new safety information before the FDA reviewed the change. Faced with stiff opposition, the FDA withdrew the rule five years later.

Speaking in support of H.R. 5668, Pallone said maintaining public trust in drug labeling is tantamount to preserving trust in the drug approval system.

Noting the length of the bill, Eshoo said that “this may seem like a small bill … but it really packs punch,” given the nation’s reliance on generics.

A decade in the making, H.R. 5534, the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act, addresses a gap in Medicare coverage by permanently removing Medicare’s 36-month limit for covering immunosuppressive drugs following a kidney transplant.

“A kidney transplant is an investment,” Burgess said. While Medicare currently pays for the transplant, as well as for ongoing dialysis and a subsequent transplant if the first one is rejected, it limits its coverage of the immunosuppressive drugs patients will have to take the rest of their lives to just three years. That doesn’t make sense, said Burgess, who noted he has been working on the issue for nearly 10 years.

Unintended consequences for devices?

A few of the other bills the subcommittee advanced raised concerns about the potential for unintended consequences for device makers. For instance, while everyone agreed that H.R. 5279, the Cosmetic Safety Enhancement Act, is long overdue, Reps. Larry Bucshon (R-Ind.) and John Shimkus (R-Ill.) worried about the wording of an amendment that would direct the FDA to prioritize the review of per- and polyfluoroalkyl substances (PFAS), which are used in cosmetics and other products, as well as in vascular grafts and devices used to fill holes in children’s hearts.

Vascular grafts with polytetrafluoroethylene, a PFAS, has been used safely in millions of patients for decades, Bucshon said. A ban on such chemicals would outlaw devices that are the standard of care, make it difficult to create new devices and lead to massive litigation against the manufacturers of what are demonstrably safe devices, he said.

Pallone committed to working on the wording before the bill goes to a markup before the full committee.

What about Rx prices?

Noticeably, none of the bills addressed drug prices, an issue that has consumed the subcommittee for the past few years. As COVID-19 grabs the headlines and the campaign season draws closer, many experts expect pricing reforms to be put on hold until after the election. “Drug pricing reform efforts that have previously caused consternation for the biotech sector have taken a back seat for now, at least at the federal level,” RBC Capital Markets LLC analyst Brian Abrahams said Wednesday.

That said, Abrahams noted, “there is still an appetite for change, and while bipartisan progress on drug pricing legislation will not occur before next year, there remain some key pricing-related events/themes to watch for – including potential inclusion of [a] drug pricing cap in a coronavirus stimulus bill, administrative implementation of some form of [international pricing index] and state initiatives on drug pricing review gaining national traction.”

However, President Donald Trump hasn’t curbed his appetite for getting something passed yet this year. He called on Congress Tuesday to finally pass a bill to rein in prescription drug prices. He also laid out basic principles a bill must have to get his signature, first of which is that it has to be bipartisan. That leaves out H.R. 3, the Lower Drug Prices Now Act, that House Democrats passed in December.

Trump said the bill also must:

  • cap the annual out-of-pocket (OOP) pharmacy expenses for Medicare Part D beneficiaries;
  • provide an option to cap Medicare Part D monthly OOP pharmacy expenses;
  • offer seniors protection against the OOP cost cliff created by the Affordable Care Act;
  • give insurance companies an incentive to negotiate better prices for costly drugs;
  • limit drug price increases.

Those principles mirror the bipartisan Prescription Drug Pricing Reduction Act drafted by Senate Finance Committee Chairman Chuck Grassley (R-Iowa) and Ranking Member Ron Wyden (D-Ore.), Grassley said. The Finance Committee forwarded the bill to the full Senate in July 2019, but it has yet to be brought to the floor for a vote, mainly because some Republicans say the bill’s limits on price increases open the door to government price-setting.

In issuing the president’s principles for drug pricing reform, the White House press secretary said, “The time is now for Congress to … set aside partisan pandering and work with this White House to deliver the most significant drug pricing reform in more than a decade.”

No Comments