A reckoning for a common cold medication

From: POLITICO's Prescription Pulse - Friday Sep 08,2023 04:02 pm

Sep 08, 2023

By Katherine Ellen Foley, David Lim and Lauren Gardner

Driving the Day

FDA scientists say that certain over-the-counter cold medicines don't relieve nasal congestion. | Getty Images

ADVISERS TO WEIGH IN ON COLD MEDS — The FDA’s independent advisers on over-the-counter drugs will meet early next week to debate whether a common ingredient in oral cold medicines should no longer be considered safe and effective.

Though there don’t appear to be any safety issues with the drugs, the meeting comes as data suggests that phenylephrine, a nasal decongestant, is ineffective at relieving stuffy noses when taken orally. In a briefing document posted Thursday, the FDA said agency scientists have confirmed the ingredient has a “high first-pass metabolism effect” when taken by mouth — in other words, it’s essentially rendered ineffective when taken as a pill or liquid medication.

The agency noted that phenylephrine administered intranasally or intravenously is effective at relieving symptoms and that a boost to the approved 40-milligram oral dosage — which has also been studied and found to be ineffective — isn’t safe because of the ingredient’s adverse effects on blood pressure.

Brief history: The FDA has studied efficacy data for phenylephrine since 2007 when two University of Florida pharmacists petitioned regulators to increase the allowed dosage for consumers 12 years and older. The pharmacists submitted another petition in 2015, requesting the ingredient be reclassified due to lack of efficacy.

Phenylephrine is found in various cold products stocked on pharmacy shelves, while drugs containing pseudoephedrine, which has been shown to be a more effective oral decongestant, are kept behind the counter. Customers must show ID to buy them.

Industry disagrees: The Consumer Healthcare Products Association, which represents drugmakers that annually earn many millions of dollars from OTC cold meds, pushed back on the petitioners’ claims in its own briefing document, arguing the data still supports phenylephrine as a safe and effective decongestant.

Voting question: Advisers are expected to vote on whether current data support the effectiveness of the approved oral dosage of phenylephrine. A negative vote could pave the way for the FDA to alter the over-the-counter clearance for nasal decongestants, and though the agency doesn’t have to follow the committee’s advice, it usually does.

IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. The D.C. State Fair may be a misnomer, but we’re still excited for it. See you there?

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).

TODAY ON OUR PULSE CHECK PODCAST, host Alice Miranda Ollstein talks with POLITICO deputy health care editor Dan Goldberg about the alarming personal medical debt in the U.S. and what some state legislators are doing about the growing crisis.

Listen to today’s Pulse Check podcast

In the Courts

Medical bottles in cardboard cartons are pictured.

The U.S. Chamber of Commerce is challenging the Medicare drug price negotiation program in court. | Brian Branch-Price/AP Photo

CHAMBER, DOJ HEAD TO COURT ON DRUG PRICE TALKS — A federal district court judge decided Thursday he will hear oral arguments on Sept. 15 in the U.S. Chamber of Commerce’s bid to stop implementation of the Medicare drug price negotiation program. The business group seeks an injunction by Oct. 1 to halt the talks while litigation winds through the courts. Oct. 1 is the deadline for the makers of the first 10 drugs selected by CMS to either agree to negotiations or face steep excise taxes. The Department of Justice, for its part, has moved to have the case dismissed.

In Congress

Sen. John Kennedy (R-La.). Photo credit: C-SPAN

Sen. John Kennedy is pushing Senate Majority Leader Chuck Schumer to step in to merge two insulin bills. | C-SPAN

KENNEDY: SCHUMER SHOULD LEAD INSULIN COMPROMISE — Sen. John Kennedy (R-La.) on Thursday called on Senate Majority Leader Chuck Schumer to broker a compromise on two bills that aim to cap the price of insulin for patients not enrolled in Medicare.

Schumer said last week that the Senate has an opportunity to advance legislation in the coming months to lower insulin costs and prescription drug prices, but no agreement has been reached to merge two dueling bipartisan proposals from Sens. Susan Collins (R-Maine) and Jeanne Shaheen (D-N.H.), and Sens. Raphael Warnock (D-Ga.) and Kennedy.

“We tried to marry those bills,” Kennedy said, noting that his bill with Warnock aims to cap the price of insulin for those without health insurance. “We haven't been able to ... what I suggested to Sen. Schumer — he’s the floor leader — he needs to marry the two himself, we need a shotgun wedding here."

Kennedy said he believes Republicans would help pass an insulin bill if the Congressional Budget Office scores it and the legislation’s cost could be funded.

SENATE TO CONSIDER FDA BUDGET — The Senate is moving to pass a minibus government funding package early next week that includes the FDA’s funding.

The chamber is expected to vote on kicking off floor debate Monday night on a three-bill package that includes fiscal 2024 funding for Agriculture-FDA, Military Construction-VA and Transportation-HUD. Collins told reporters she hopes for “a robust amendment process.”

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Tobacco

MENTHOL-LIKE CIGARETTE SALES FLATTEN — Preliminary sales data through August shows that sales of so-called “California compliant” cigarettes that mimic menthol have stalled after gaining traction earlier this year.

“Momentum for pseudo-menthols has stopped,” Alex Liber, an assistant professor at Georgetown University’s School of Medicine’s oncology department who studies tobacco sale trends, told Prescription Pulse. In California, the cigarettes had replaced 50 percent of Camel menthol cigarette sales and 34 percent of Newport cigarette sales as of March but have since failed to advance further.

Tobacco giant R.J. Reynolds began to sell cigarettes with a menthol substitute in California in December 2022, just as the state banned most flavored tobacco products. California makes up the largest market for Reynolds’ new cigarettes, though they are also sold in small numbers in Massachusetts and Maine. The company said it does not comment on sales figures.

Liber noted that overall cigarette sales in California have also decreased this year. But he said that without further analysis, it was not clear that the new sales figures mean smokers are quitting because of the statewide flavor ban.

Pharma Moves

Barbara Kowalcyk has been named the first director of the new Center for Food Safety and Nutrition Security at George Washington University’s Milken Institute School of Public Health. Kowalcyk is director of the Center for Foodborne Illness Research and Prevention at Ohio State University and serves as chair of the FDA’s Science Board. Jane Grogan will serve as Biogen’s executive vice president and head of research beginning Oct. 2.

Erik Komendant joins Whitmer & Worrall, a consulting and government relations firm, as a principal lead in the firm’s health care practice. Previously, he was head of government affairs at generics lobbying firm Association for Accessible Medicines and insurance lobbying group America’s Health Insurance Plans.

Quick Hits

A surge in demand has led to stool softener shortages, Rachel Wolfe reports for The Wall Street Journal.

State lawmakers are enacting consumer protections to help the roughly 100 million adults living with medical debt they can’t afford to pay, Dan Goldberg writes for POLITICO.

Document Drawer

The CDC’s Advisory Committee on Immunization Practices will meet Sept. 22 to discuss Pfizer’s maternal respiratory syncytial vaccine.

The FDA finalized guidance Thursday that outlines a risk-based approach for whether biocompatibility testing is needed for medical devices using an international standard.

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