Consumers head to court on OTC cold pills

By Lauren Gardner, Katherine Ellen Foley and David Lim

Presented by Pharmaceutical Care Management Association

Class-action lawsuits on behalf of consumers target drug companies that produce cold medicines with ingredients deemed ineffective by FDA advisers. | Spencer Platt/Getty Images

CONSUMERS TAKE ON COLD MED MAKERS — Now that the FDA’s outside experts have unanimously determined the meds’ active ingredient is ineffective, regulators must decide whether to pull many of the most popular nonprescription cold meds off store shelves. In the meantime, people are filing suits seeking damages for the products they’ve already purchased.

At least two class-action lawsuits were filed this week in federal courts in Florida and New Jersey on behalf of consumers who purchased over the counter, phenylephrine-containing oral medications made by Johnson & Johnson, Procter & Gamble, Reckitt Benckiser, Kenvue, GSK and Walgreens. Those companies make popular cold meds that include Sudafed, Vicks NyQuil, Tylenol and Benadryl.

The Florida lawsuit seeks orders prohibiting the sale of certain cold products and requiring a recall and corrective advertising campaign, in addition to damages. The New Jersey lawsuit aims to force the companies to disclose how long they knew the ingredient was ineffective but continued to sell the products anyway.

What the FDA experts’ recommendation vote means: The advisers’ vote Tuesday panning the effectiveness of phenylephrine opens the door to the FDA yanking pills that contain the ingredient off store shelves. The FDA doesn’t have to follow its committees’ advice, but it typically does.

Still, any such move is a ways off, and while FDA staff who reviewed the most recent phenylephrine studies agree that the current dosage is ineffective, the experts’ vote doesn’t determine what the FDA might do next even though the agency usually follows its committees' advice. The agency issued a statement Thursday that it said “clarifies” the results of the Tuesday meeting.

“FDA will consider the input of this advisory committee, and the evidence, before taking any action on the status of oral phenylephrine,” it said.

If the FDA determines the ingredient is ineffective when taken orally — its inclusion in inhalers isn’t being debated — the regulator would issue a proposal pulling its “safe and effective” status. The agency would then take public comment before deciding whether to issue a final order.

“FDA would then work closely with manufacturers to reformulate products as needed to help ensure availability of safe and effective products to treat symptoms of colds or allergies,” the agency said.

The way forward: Jason Richards, an attorney leading the Florida lawsuit against J&J and Procter & Gamble, said he expects multiple lawsuits to be filed nationwide and eventually consolidated into multidistrict litigation.

A settlement could yield millions of dollars in proceeds going back to consumers who purchased the medications, he said.

“So many millions of people have used these products that seemingly everyone has one under their kitchen cabinet or bathroom cabinet,” he said.

Most named companies didn’t respond to requests for comment, and Walgreens declined to comment on active litigation. But it’s worth noting that J&J spun off its consumer health portfolio into Kenvue last year, and GSK made a similar move with Haleon, to which it referred questions.

IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Might fall weather be on the horizon in D.C.? We’ve got our fingers crossed.

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

A message from Pharmaceutical Care Management Association:

Why is Congress making it easier for Big Pharma to raise drug prices and boost profits at the expense of patients and taxpayers? Misguided proposals want to restrict PBM tools but would actually INCREASE drug costs and invite Big Pharma to collude on drug prices under the guise of “transparency” – rigging the system against patients yet again. Reject anti-PBM reforms that will keep drug prices high and offer a massive windfall to Big Pharma.

TODAY ON OUR PULSE CHECK PODCAST, host Alice Miranda Ollstein talks with POLITICO global health care reporter Carmen Paun on how former President George W. Bush and a group of establishment Republicans are working to convince anti-abortion groups and conservatives to support reauthorizing the global HIV/AIDS program.

The FDA's Orange Book contains improper patents that block cheaper generic drugs from coming to market. | Jean-Christophe Verhaegan/AFP/Getty Images

BIDEN ADMIN ENLISTS THE ORANGE BOOK TO TACKLE DRUG PRICING — The FTC voted unanimously Thursday to issue a policy statement on patents listed in the FDA’s Orange Book that the agency finds to be blocking generic drug competition.

The FDA publishes annual records of approved drugs and patents pertaining to them, allowing generic companies to see which drugs’ patents might be expiring. Improper patents refer to those listed in the Orange Book that pertain to the drug cited, which could be erroneously used to prevent cheaper alternatives from coming to market.

FTC Chair Lisa Khan said during the meeting that improperly listed drug patents are “a real problem and one that could really be contributing to unaffordable medicines and drug products.” She noted that improper patents may have negatively affected the development of generics for brand-name drugs and medical devices for the past 30 years.

The FTC committed to act against improper patents in a policy statement issued after the meeting, which was met with support from the nation’s top drug regulator. “The FDA stands ready to assist the FTC as part of our long history of collaboration to protect American consumers,” FDA Commissioner Robert Califf said in a statement.

But some experts worry that the FTC’s efforts will backfire. Even if removing improper patents paves the way for more generics to enter the market in the near term, “long term, [the agency is] discouraging generic companies from trying to test patents,” Rohit Singla, a partner with the law firm Munger, Tolles and Olson who focuses on antitrust, told Prescription Pulse.

He explained that an unintended consequence of removing improper patents is that brand-name companies could sue generic manufacturers after they bring a product to market, citing patents struck from the Orange Book by the FTC. The litigation could result in major financial expenses for generic manufacturers even if they prevail in court. And if they don’t, they might suffer major financial losses in addition to their products being pulled from the market.

JOIN US ON 9/20 FOR A TALK ON TRANSFORMING HEALTHCARE BILLING: Bipartisan legislation in the House and Senate would align costs for services across hospitals and doctors’ offices and reduce out-of-pocket spending that could potentially save the federal government billions of dollars. Can this legislation survive a polarized Congress? Join POLITICO on Sept. 20 to explore this and whether site-neutral payments and billing transparency policies could help ease health care costs. REGISTER HERE.

DRUG SHORTAGES REDUX — House lawmakers on Thursday peppered generic drugmakers, distributors, pharmacists and drug policy experts about five bills that aim to reduce and mitigate drug shortages, but a path forward for bipartisan legislation is unclear amid a government funding battle overshadowing committee-level dealmaking.

Top committee leaders indicated they’re open to developing a bipartisan drug shortage package, but the hearing did not yield much clarity on what a compromise might look like or whether one like Democrats are pressing for can be achieved this year.

Energy and Commerce Health Subcommittee Chair Brett Guthrie (R-Ky.) noted that the main GOP bill is a discussion draft and lawmakers continue to solicit outside input in hopes of finding bipartisan consensus. But not a lot of legislative days are left this year, and lawmakers should not be working on a clock, he said.

“We’re getting a lot of feedback right now, so I’m going to make sure we get it right,” Guthrie told reporters, adding that he wants to work quickly. “Is it possible to do some components on some other bill? Perhaps. Everything, in my view, is on the table.”

TROUBLE IN PARADISE — A cold front collided with clear skies in the Senate on Thursday when progress toward passage of a trio of spending bills — including FDA funding — ground to a halt after Sen. Ron Johnson (R-Wis.) blocked a bipartisan effort to consider several amendments, POLITICO’s Caitlin Emma reports.

The staunch conservative opposes bundling appropriations bills, but the decision drew the ire of Sen. Susan Collins of Maine, the top Republican appropriator, and Senate Appropriations Chair Patty Murray (D-Wash.).

By holding up this bundle of spending bills, Collins said Johnson is “setting us up for either an omnibus bill or a government shutdown.” Omnibus refers to a massive 12-bill spending package that Congress has historically rushed through in the 11th hour with little debate.

A message from Pharmaceutical Care Management Association:

MODERNA COVID SHOT GETS EU OK — The European Medicines Agency has recommended Moderna’s updated Covid-19 vaccine for people ages 6 months and older, the company announced Thursday. The European Commission gets the final say on whether to agree with the EMA’s decision.

JOIN 9/19 FOR A TALK ON BUILDING THE NEW AMERICAN ECONOMY: The United States is undergoing a generational economic transformation, with a renewed bipartisan emphasis on manufacturing. Join POLITICO on Sept. 19th for high-level conversations that examine the progress and chart the next steps in preserving America’s economic preeminence, driving innovation and protecting jobs. REGISTER HERE.

The FDA published a handful of medical device guidance documents, including its breakthrough devices program and how device makers can engage with the agency’s Voluntary Improvement Program. It also published draft guidance on the clinical study of medical devices with indications associated with weight loss.

A message from Pharmaceutical Care Management Association:

Big Pharma is the link between patients and high drug prices. And now, Congress is considering several misguided proposals that could put $10 billion a year back in Big Pharma's pocket while also giving them even greater power to keep drug prices high by inviting anti-competitive collusion on price.

Why does Congress want to let Big Pharma boost their own profits at the expense of patients and taxpayers?

Restricting PBM tools will increase – not decrease – drug costs. And now there’s data to prove it. PBM reforms will cost taxpayers, keep drug prices high and offer a massive giveaway to Big Pharma. It's time to reject proposals that mean big profit windfalls for Big Pharma and higher drug costs for hard-working Americans.

Get the facts.

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