| | | | |  | | By David Lim, Lauren Gardner and Katherine Ellen Foley | Presented by the Pharmaceutical Care Management Association | With help from Olivia Olander
| | | — The top Republican on the Senate HELP Committee shakes up FDA user fee reauthorization negotiations. — The FDA issues first warning letters to synthetic nicotine vape companies. — Bicameral Democrats reintroduce legislative effort to separate food oversight from the FDA. It's Friday. Welcome to Prescription Pulse. Are you Senate Majority Leader CHUCK SCHUMER? We want to hear your scheduling plans for the FDA user fee package. Send tips and feedback 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: PBMs are working to lower patient costs for insulin . But the INSULIN Act will increase insulin costs while giving drug manufacturers another way to game the system to maximize profits. Drug manufacturers alone set insulin prices. Rather than increasing pharma's profits, Congress should take on drug companies by addressing the root cause of high insulin costs: their price setting.
PBMs support reducing insulin costs for patients. Learn more about PBM efforts to lower insulin costs. | | | | | | | 
Sen. Richard Burr (R-N.C.) has had enough of trying to negotiate a bipartisan FDA user fee reauthorization package. | Graeme Jennings-Pool/Getty Images | BURR UNDER DEMS' SADDLE — Senate HELP Committee ranking member Richard Burr (R-N.C.) is done trying to negotiate a wide-ranging FDA user fee reauthorization package that includes yearslong efforts to revamp oversight of diagnostics, dietary supplements and cosmetics. The powerful Republican on Thursday introduced a spartan bill that simply reauthorizes the underlying user fee agreements for five years and strips out major riders and amendments. "Everyone seems to want to blame me for holding up user fees. I don't want to hold it up," Burr told POLITICO. "I'm ready to go, let's do it. I'm willing to throw everything overboard to make sure this program continues. Now I'll see if my colleagues are willing to do the same." Hours later, the bipartisan leaders of the House Energy and Commerce Committee issued a joint statement squarely pinning the package's delay on the Senate. "We urge Senate leaders to bring our strong bipartisan package to the floor for a vote before August," said Chair Frank Pallone (D-N.J.) and ranking member Cathy McMorris Rodgers (R-Wash.). "There is no reason for the Senate to reject the strongest and best path forward to ensure this reaches the president's desk." At risk: If Congress doesn't reach a deal soon, the FDA may have to send out furlough notices at the start of August to thousands of employees, warning that their jobs are in danger. But the agency has significant carryover balances from its user fee program, meaning layoffs could be delayed. FDA Commissioner Robert Califf advocated for speedy passage of the package during a Tuesday interview with the Alliance for a Stronger FDA, acknowledging the specter of layoffs. If the legislation is passed late, replacing employees amid so many ongoing processes and decisions could delay key agency decisions on medical products, he added. Senate HELP Committee Chair Patty Murray (D-Wash.) said on Thursday that she still wants to move forward with the broader bill that has already advanced out of committee, while acknowledging that FDA layoffs "should be unacceptable to all of us." "It makes absolutely no sense to back out of bipartisan negotiations now," Murray said. "I urge Senator Burr to return to the table and finish what he started." On the House side: Energy and Commerce leaders signaled Thursday that, from their perspective, the holdup on moving the legislation to President Biden's desk is coming from the Senate. "This is no time for the FDA employees to get pink slips. My goodness, the work has been done," said E&C Health Subcommittee Chair Anna Eshoo (D-Calif.). "We did our work here, and we did it on a timely basis." E&C Health Subcommittee ranking member Brett Guthrie (R-Ky.) said he hasn't yet talked to Burr about the stripped-down user fee bill but argued the House bill is a good vehicle. "There needs to be some understanding of how much money FDA does have — does that keep them operating until we can get something done?" Guthrie said. "But, then again, uncertainty is always bad, and if we can give them certainty, I think sooner rather than later is better." Talks are ongoing: Staff-level negotiations on the major regulatory overhauls are still underway, according to congressional aides and lobbyists. Some speculate that Burr — typically a levelheaded lawmaker — is engaging in carefully calculated brinkmanship and he aims to ultimately advance a user fee package that has his stamp on it. But don't count on a broad bill moving forward. "Legacies mean nothing to me," Burr said. "I reformed the FDA 25 years ago. There's nothing at the FDA that doesn't have my name on it."
| | | | DON'T MISS DIGITAL FUTURE DAILY - OUR TECHNOLOGY NEWSLETTER, RE-IMAGINED: Technology is always evolving, and our new tech-obsessed newsletter is too! Digital Future Daily unlocks the most important stories determining the future of technology, from Washington to Silicon Valley and innovation power centers around the world. Readers get an in-depth look at how the next wave of tech will reshape civic and political life, including activism, fundraising, lobbying and legislating. Go inside the minds of the biggest tech players, policymakers and regulators to learn how their decisions affect our lives. Don't miss out, subscribe today. | | | | | DEMS PROPOSE SPLITTING FDA TO GIVE FOOD MORE FOCUS — House Appropriations Chair Rosa DeLauro(D-Conn.) teamed up with Senate Majority Whip Dick Durbin (D-Ill.) this week to reintroduce legislation that would create a new food-safety agency housed under HHS, a move that essentially takes the "F" out of the FDA. "Look no further than the recent infant formula crisis to understand the need to create a single food safety agency, led by a food policy expert, to ensure the safety of products that go to market," DeLauro said in a statement. Prospects? The idea is unlikely to move forward, given the political realities on Capitol Hill where lawmakers may be reluctant to lose jurisdiction if the proposed standalone food center is housed squarely within HHS. Rep. Sanford Bishop (D-Ga.), chair of the House Appropriations panel on Agriculture Department and FDA spending, said DeLauro is "very passionate about protecting the health, safety and welfare of consumers when it comes to food." When asked whether he'd be amenable to losing jurisdiction of the FDA, Bishop said: "Well, I just want to look at the legislation and evaluate the pros and the cons and see where I think it best fits, and we'll see what happens." Firm opposition: Former FDA Commissioner Scott Gottlieb criticized the proposal to split up the FDA, saying the move would cause the food center to lose a "public health mindset" and become more like the U.S. Department of Agriculture. And Califf said Tuesday that he wants the FDA to receive more funds to bolster the historically underfunded food side of the regulatory agency. "There's no way to fully preserve the public health DNA of the organization if you detach it from FDA," Gottlieb said. "There was a lot of cross-fertilization of cross-center ideas and goals that informed how we leveraged nutrition and food policy as part of a larger public health agenda. You lose that. You lose the culture and you lose the connections." Burr told POLITICO he agreed with Gottleib's perspective, saying it was "a safe assessment" of the potential implications of splitting up the FDA.
| | | | A message from the Pharmaceutical Care Management Association:   | | | | | | | 
Sen. Dick Durbin (D-Ill.) says that vapes should be regulated as medical products. | Francis Chung/E&E News | FDA ISSUES FIRST WARNING LETTERS ON SYNTHETIC NICOTINE — Late Wednesday evening, the Food and Drug Administration announced it had issued its first two warning letters to companies making vapes containing lab-made nicotine, Katherine reports. Those companies, AZ Swagg Sauce LLC and Electric Smoke Vapor House, failed to file a marketing application by May 14 for the approximately 10,000 products. The FDA sent the letters because Congress passed a law in the spring that stated, as of July 13, all synthetic vape products without marketing authorization would become illegal. The agency also issued warning letters to more than 100 companies that it claims have been selling synthetic nicotine e-cigs to minors. The FDA continues to evaluate approximately 1 million marketing applications for other synthetic vape products from more than 200 companies that can likely remain on retailers' shelves. Applications in waiting: But it's far from certain how the agency will deal with those synthetic vape products. The FDA to date has used "enforcement discretion" on vapes with tobacco-derived nicotine, including products from major market player Vuse, which means manufacturers can continue to sell their products until they get a final decision. The agency didn't respond with a comment on Thursday. A simmering senator: Senate Majority Whip Dick Durbin (D-Ill.) was highly displeased with the agency's announcement. "This synthetic nicotine enforcement announcement is woefully deficient. The agency is failing to fulfill its legal obligation to clear the market of unauthorized products, which is particularly unacceptable given FDA's recognition of the public health threat to children posed by these synthetic e-cigarettes," he said in a statement to POLITICO. Durbin has already called for FDA Commissioner Robert Califf to resign over the unauthorized tobacco-derived nicotine vapes remaining on the market. Although the seasoned anti-smoking lawmaker doesn't have direct power over the FDA, he is well-positioned to apply external pressure to the agency as the Senate's No. 2 Democrat. What Durbin wants: Durbin believes that, in an ideal world, the regulation of vapes wouldn't even fall under the Center for Tobacco Products; they would be regulated as medical products instead. "In my mind, they should be prescribed," he said in a separate interview with POLITICO.
| | | | INTRODUCING POWER SWITCH: The energy landscape is profoundly transforming. Power Switch is a daily newsletter that unlocks the most important stories driving the energy sector and the political forces shaping critical decisions about your energy future, from production to storage, distribution to consumption. Don't miss out on Power Switch, your guide to the politics of energy transformation in America and around the world. SUBSCRIBE TODAY. | | | | | | | | DOCS LAMENT SLUGGISH KIDDIE VAX UPTAKE — States that have already seen low demand for Covid-19 vaccines among older children are ordering fewer doses for kids under 5 who are newly eligible for immunization, Lauren and POLITICO's Krista Mahr report. While experts agree that states shouldn't order more vaccines than they think they'll use, they fear it's a signal of parents' growing ambivalence over immunizing children against the disease, not to mention the politicization of health care. NOVAVAX ENTERS THE COVID-19 VACCINE ARENA — The FDA authorized the two-dose Novavax Covid-19 vaccine on Wednesday, making it the fourth shot available to adults since the start of the pandemic and the only candidate to use a recombinant protein to generate immunity, Katherine and David report. The agency endorsed the shot for the roughly 10 percent of adults who have yet to receive any Covid-19 immunization. For context: The authorization, scooped by POLITICO's Adam Cancryn and Katherine on Tuesday, comes at a time when the Biden administration is stressing that vaccinations and boosters are key to preventing Covid hospitalizations and deaths as the BA.4 and BA.5 subvariants of the Omicron strain dominate infections across the country. Novavax executives have expressed hope that this option, which was 90.4 percent effective at preventing Covid-19 infections during the Alpha wave of the coronavirus, will appeal to those allergic to components of other vaccines or skeptical of the newer technology in some other vaccines. EMA weighs in: The European Medicines Agency on Thursday announced it would include anaphylaxis — a severe allergic reaction — as a potential side effect of the Novavax shot, causing a heavy slide in the vaccine maker's stock price.
| | | On Thursday, the Congressional Budget Office released its score of a bill by Sens. Jeanne Shaheen (D-N.H.) and Susan Collins (R-Maine) to cap out-of-pocket costs for insulin.
| | | | A message from the Pharmaceutical Care Management Association: America's pharmacy benefit managers (PBMs) support lower insulin costs, and have taken steps to reduce out-of-pocket costs for patients relying on insulin.
The INSULIN Act won't lower insulin costs. It gives Big Pharma companies another way to game the system to maximize profits. Rather than lining pharma's pockets, Congress should take on manufacturers to reduce costs: increasing competition among insulin manufacturers and stopping patent abuses that block generic and biosimilar insulins from reaching the market for patients to use.
It's simple. Insulin prices are high because there are only a few insulin manufacturers, shielded from competition, and those companies set and raise prices. PBMs, on the other hand, are the only entity in the prescription drug supply and payment chain dedicated to reducing drug costs. On average, PBMs reduce patient drug costs by nearly $1,000 every year.
Learn more about how PBMs are working to lower insulin costs. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
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