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Presented by Patients For Affordable Drugs Now: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | | |  | | By Lauren Gardner and David Lim | Presented by Patients For Affordable Drugs Now | With help from Katherine Ellen Foley | | | — The FDA faces a Thursday deadline to approve or reject the sale of millions of e-cigarettes. It’s likely to miss it for some products. — The agency sees growing pressure to green light Covid-19 vaccines for kids under 12 as children return to school. — The Biden administration is walking back its Covid booster plan after an outcry from public health experts. It’s Wednesday. Welcome back to Prescription Pulse. It’s been a busy 12 days since we were last in your inbox, but we’ve got you covered. Be sure to send tips to Lauren Gardner (lgardner@politico.com or @Gardner_LM), David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). | | A message from Patients For Affordable Drugs Now: Americans pay almost four times what people in other wealthy nations pay for the same brand name drugs. In the U.S., 1 in 3 adults don’t take medications as prescribed because they’re too expensive. The CBO says lower drug prices would increase access and improve health. Congress can address the problem now by allowing Medicare to negotiate drug prices. 90% of voters—including Democrats, Independents, and Republicans—support it. It’s time to get it done. Learn More. | | | | | | FDA NEARS DAY OF RECKONING ON E-CIGARETTES — The Food and Drug Administration must decide whether millions of e-cigarette products are “appropriate for the protection of public health” by Sept. 9 — a decision that could potentially reshape the entire vaping industry, Katherine writes. Previously, makers and sellers of e-cigarettes had operated without many of the restrictions on sales and marketing created to regulate traditional tobacco products. But FDA has come under increasing pressure from politicians and public health groups in recent years to limit the e-cig sales, largely over concerns about the flavored products’ popularity with teenagers. E-cigarette companies argue that flavored varieties are keystones for their adult customers and can lure smokers into switching to less-damaging products. “FDA really is at a critical juncture,” said Matthew Myers, the president of the Campaign for Tobacco-Free Kids. “In some critical ways how FDA will be perceived will probably be defined with what it does now with regard to pending applications.” No matter what FDA’s ultimate decision is on e-cigarettes, some parties will be angry — and may take legal action against the agency. “I can't in my mind see the FDA threading a needle here that doesn't result in litigation from someone,” said Desmond Jenson, a lawyer at the Public Health Law Center at the Mitchell Hamline School of Law who focuses on commercial tobacco policy. “It's kind of impossible.” | | | | STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president’s ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today. | | | | | | | | CALLS MOUNT ON FDA TO AUTHORIZE KID VACCINES FOR COVID — The biggest pandemic stories that closed out unofficial summer have a common theme: People would like science and regulators to hurry up, please. In the case of vaccinating children against Covid, some say there’s enough data to make a call and the tweaked size and follow-up period FDA required for kid trials may slow down a shot’s availability for little benefit. Now politicians are joining the chorus of anxious parents who want to see their kids vaccinated as after-school activities and cold weather loom, even though Pfizer — the only manufacturer close to getting its shot reviewed for those under 12 — isn’t expected to submit its safety and efficacy data until sometime this month. Hospital admissions for unvaccinated teens and kids 4 and under have risen tenfold since mid-June, and deaths will likely tick up. Still, public health officials agree there are ways to prevent Covid infection among children — mask-wearing in public spaces and classrooms, physical distancing, increased ventilation and vaccinating all eligible individuals who interact with youths. The question is whether states like Florida that have eschewed such measures will reverse course before vaccines are available for kids. BIDEN TO DELIVER MAJOR COVID-19 SPEECH THURSDAY — President Joe Biden will lay out a “six-step plan” aimed at combating the pandemic on Thursday, White House Press Secretary Jen Psaki told reporters Tuesday. A source familiar with the speech told POLITICO on Tuesday that Biden “is expected to announce new efforts to boost testing and access to them.” WHITE HOUSE DELAYS BOOSTER ROLLOUT AMID DATA OUTCRY — The White House is pumping the brakes on its booster shot rollout after top health officials warned the Biden administration they may not have adequate data by the Sept. 20 target date to grant regulatory approval. The original plan envisioned making third doses of the Pfizer and Moderna vaccines available by that date to those who’d received their second shots at least eight months ago, targeting the earliest recipients, who included the elderly and frontline health care workers. The decision to scale back came in part because Moderna’s booster data was only just submitted to the FDA last week, POLITICO’s Sarah Owermohle and Erin Banco write. FDA’s external vaccine advisers will hold their meeting on Pfizer’s booster application on Sept. 17, which could set up that vaccine to get the booster green light in some fashion days later. But the administration’s approach came under fire from medical professionals and the like, who argued that politicians were trying to end-run long-standing regulatory practice at a time when the federal government can ill-afford more vaccine hesitancy. Those concerns surfaced during an official forum just days before, when CDC’s own outside vaccine advisers voiced frustration with the White House’s strategy, Lauren reports. One official’s presentation made it clear government scientists want to prioritize the prevention of severe, instead of all, disease in at-risk groups, when endorsing boosters. WHITE HOUSE CALLS FOR $65B PANDEMIC PREPAREDNESS ‘APOLLO PROGRAM’ — Biden science advisers on Friday called for the creation of a $65.3 billion overhaul of the nation’s pandemic preparedness infrastructure to protect against the “reasonable likelihood” of another serious pandemic — which might be worse than Covid-19 — in the years ahead. WHILE YOU WERE OUT OF THE OFFICE — That’s not the end of the coronavirus news we’ve tracked in the last few weeks. Here’s a quick roundup of Pro headlines so you can get up to speed: Two senior vaccine regulators announced their retirements from FDA last month, partly because of how booster decisions were being managed among agencies, our David Lim and Sarah report. CDC advisers unanimously supported recommending Pfizer’s vaccine for those 16 and older, formally endorsing FDA’s product licensure. Colleges are pivoting from carrots to sticks to coax students to get vaccinated, with institutions using everything from fines to expulsion to force the issue, Daniel Payne reports. House panels ask FDA for more information about the controversial Alzheimer's drug approval as part of their ongoing investigation into Aduhelm’s pricing and approval, Katherine reports. | | | |   | | | | | | DRUG INDUSTRY BANKS ON ITS COVID CLOUT TO HALT DEMS’ PUSH ON PRICES — Lobbyists for the pharmaceutical industry are warning lawmakers about the $3.5 trillion reconciliation package , which is set to include language that would allow Medicare to negotiate some drug prices, report Hailey Fuchs, Alice Miranda Ollstein and Megan Wilson. Proponents of the bill, which is moving through both chambers of Congress, argue that it would generate billions of dollars in savings. But lobbyists argue that now isn’t the time to hit the industry with new regulations or taxes, particularly in light of its successful efforts to swiftly develop vaccines for the virus. A lawmaker has his reservations, too: In an op-ed published last Thursday, Sen. Joe Manchin (D-W.Va.) urged Dems to pause efforts to pass the social spending bill because of concerns about inflation and the debt it would cause Marianne Levine writes. He suggested he would be open to a pared-back version — but his piece could make it difficult for progressives to push the legislation through by the month’s end. | | | FDA ANNOUNCES PILOT PROGRAM FOR NOVEL EXCIPIENTS — The Center for Drug Evaluation and Research is launching a pilot program aimed at getting manufacturers’ new excipients reviewed before they are used in drugs. “The Pilot Program seeks to foster development of excipients that may be useful in scenarios in which excipient manufacturers and drug developers have cited difficulty in using existing excipients,” a Federal Register notice announcing the initiative states. | | | ILLUMINA, MERCK PARTNER ON CANCER TESTS — Illumina and Merck announced Tuesday they are working together on developing and commercializing companion diagnostics that can identify genetic mutations used to determine if tumors are homologous recombination deficiency-positive. | | | J&J HIV VACCINE NOT EFFECTIVE IN WOMEN — Johnson & Johnson’s HIV vaccine candidate didn’t sufficiently protect young women in sub-Saharan Africa at high risk of contracting the virus, the company reported last week. The study into the shot, estimated to be 25 percent effective, won’t continue. | | | Megan Burke is now a director of government relations at The Petrizzo Group, focused on health care. She previously worked as deputy chief of staff to Ways and Means Committee Ranking Member Kevin Brady (R-Texas). PCMA announced last week Jack Linehan is joining the trade group as its general counsel, Agnita Kote as its CFO and Zach Pleasant as director of technology and operations. Amanda Frost has been promoted to vice president of research. | | | | Be a Policy Pro. POLITICO Pro has a free policy resource center filled with our best practices on building relationships with state and federal representatives, demonstrating ROI, and influencing policy through digital storytelling. Read our free guides today . | | | | | | | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA. Multiple Myeloma drug scrutiny — The FDA plans to convene its Oncologic Drugs Advisory Committee next month to reconsider the approval of Pepaxto, an intravenous fifth-line treatment for multiple myeloma that was approved in February 2021 under the agency’s accelerated approval pathway. Approvals under the accelerated pathway use “surrogate” endpoints that indicate that the treatment is likely to result in benefits to a patient, allowing it to be approved more quickly than waiting for a more definitive endpoint (such as overall survival). Recent data from a confirmatory trial for Pepaxto determined that rather than benefiting patients, the drug was instead associated with an “increased risk of death,” for which the FDA issued a warning to health care providers in July. FDA has recently pushed to withdraw the approval of several other drugs initially granted accelerated approval after their confirmatory studies failed to demonstrate a positive effect. FDA stands by decision on electrotherapy devices — The FDA last week rejected a petition from a manufacturer of cranial electrotherapy stimulator (CES) devices, saying that its decision to reclassify the devices after almost a decade of discussion and debate had been appropriate. Fisher Wallace Laboratories had petitioned the agency after regulators determined that the devices, which apply electrical current to a patient’s head to treat behavioral/mental health disorders, should be regulated as either Class II (moderate-risk) or Class III (high-risk) depending on their exact indication for use. Fisher Wallace raised concerns about both the circuitous classification process and the Class II/III designations, stating that the regulatory bar set for both categories of device was too high. FDA rejected these arguments, citing a lack of evidence that the devices are effective for their intended uses – even if they are already marketed. | | | The Wall Street Journal detailed what it takes for one Covid-19 kid vaccine trial site to administer doses to child participants. Joanne Kenen describes the political challenge ahead for the Biden administration and public health officials to effectively communicate about pandemic progress when “normal” will look different. | | | FDA published two draft guidances outlining Safety and Performance Based Pathway information for denture base resins and facet screw systems. FDA is requesting nominations for people to serve on its Tobacco Products Scientific Advisory Committee. | | A message from Patients For Affordable Drugs Now: Drug corporations will stop at nothing to maintain their monopoly power to price drugs as high as they want at the expense of patients. The industry is spending millions on ads pushing false claims to scare patients and stop lawmakers from allowing Medicare to negotiate lower prices.
Fact: The biggest barrier to patient access is price. Lower drug prices achieved by negotiation will increase access and improve health.
Fact: We can have innovation we need at prices we can afford. The CBO concluded even deep cuts to pharma revenue would result in only minor reductions in new drugs coming to market.
Fact: Only 10-15% of new drugs represent true therapeutic advancements. We can maintain or even increase innovation by making clear we’ll pay the best prices for the best drugs, and by sending savings to the NIH to drive groundbreaking science.
90% of voters support Medicare negotiation. Congress can get it done now. Learn More. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |  |
