|
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 David Lim and Lauren Gardner | Presented by Patients For Affordable Drugs Now | With help from Katherine Ellen Foley and Megan R. Wilson ON TAP — Biden lays out broad vaccine requirements as part of a multi-pronged plan that tries to tackle the Delta surge. — FDA boots over 5 million e-cigs from the market, drastically reshaping the vaping industry while delaying decisions on key players. — House Democrats plan to include legislation empowering the federal government to negotiate Medicare drug prices in their budget reconciliation package. It’s Friday. Welcome back to Prescription Pulse. Slow news day, huh? 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. | | | | | | BIDEN LAYS OUT BROAD VACCINE REQUIREMENTS TO REIN IN COVID — President Joe Biden on Thursday announced a set of ambitious plans to implement vaccine requirements for health facilities that receive federal funding, federal employers and contractors, and businesses with more than 100 employees in a bid to gain control over the worst wave of Covid-19 infections since last winter. The requirements are part of a broader six-part blueprint for combating the pandemic that Biden unveiled in a speech Thursday evening. Dubbed “Path out of the Pandemic ,” it outlines new initiatives aimed at boosting vaccinations and access to testing, insulating the economy, keeping schools open, expanding mask requirements and improving care for Covid-19 patients. “This is not about freedom and personal choice. It’s about protecting yourself and those around you," Biden said. He added, "The bottom line, we're going to protect vaccinated workers from unvaccinated coworkers." The new vaccine requirements cover approximately 100 million workers, about two-thirds of all American workers, according to Biden. The Labor Department and Occupational Safety and Health Administration are expected to issue a rule "in the coming weeks" that will lay out the exact timeframe for the new requirements. Those who do not comply with the OSHA standard could face fines up to $14,000 per violation, a senior administration official told reporters. White House Press Secretary Jen Psaki said earlier Thursday that federal workers would have 75 days to comply with the mandate, unless they qualify for limited exemptions. — The administration’s blueprint also weighed in on booster shots. “By planning now, we will be able to quickly get booster shots into the arms of eligible Americans once approved,” the plan reads. “As soon as authorizations are given, the Administration will be prepared to offer booster shots, starting the week of September 20th.” — Revving up monoclonal antibody deliveries. Biden also said the administration will boost the availability of monoclonal antibody treatments by expediting the average shipment pace by 50 percent. He suggested that he won’t extend the policy to ivermectin — the horse dewormer paste that’s gained traction in some unvaccinated quarters — by calling the monoclonal antibodies “medicines recommended by real doctors, not conspiracy theorists.” — Government readies purchase of 280 million at-home rapid tests. The Biden administration plans on spending nearly $2 billion to buy over-the-counter tests from multiple diagnostic manufacturers to boost testing in long-term care facilities, community testing sites and other settings. But it remains unclear how quickly the administration will be able to procure the rapid tests, which have been in shortage due to overwhelming demand. Walmart, Amazon and Kroger are also being tapped to sell Covid-19 tests at cost for the next three months, and efforts are being made to expand the number of retail pharmacies where people can be tested. Community health centers and food banks are also getting 25 million rapid tests to distribute to further expand access to testing. | | | | 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. | | | | | BUT THE U.S. TESTING SYSTEM IS STRUGGLING TO KEEP UP WITH DELTA DEMAND — The slate of new Covid-19 initiatives comes shortly after test manufacturers, commercial and public health labs, and public health experts pushed the administration to reopen mass-testing sites that were repurposed as vaccination sites earlier this year to take advantage of excess lab-based capacity across the country. “Communities moved away from mass testing sites because there was not the demand, and that needs to be reversed,” said Scott Becker, CEO of the Association of Public Health Laboratories. “And we need to have a consistent approach to easy access for testing, be it rapid testing or lab-based testing with an increase in collection sites.” Retail pharmacies including CVS have put into place restrictions on the number of rapid at-home tests consumers can buy at one time due to overwhelming demand for the products. Another problem is that results from the rapid tests are reported to public health authorities infrequently, making it more difficult to understand the spread of the more transmissible Delta variant. The 51.5 million Covid-19 tests recorded by the CDC in August included 11.5 million rapid antigen tests. But HHS estimates that the number of rapid tests actually performed was much larger: 80.2 million. K STREET HEALTH SHOPS EMBRACE VAX MANDATES — More than a dozen health care trade groups announced Thursday that they’ll require employees to be fully vaccinated against Covid to return to their offices, saying that “preserving the public health is core to our missions.” The organizations include the Association of Schools and Programs of Public Health, the Alliance of Community Health Plans and the National Pharmaceutical Council (h/t POLITICO Influence’s Caitlin Oprysko). MODERNA, NOVAVAX MOVE ON COMBO COVID, FLU SHOTS — The domestic vaccine makers announced their plans this week as flu season lurks behind the autumnal equinox. Moderna’s shot is intended to be a booster for both viruses, while Novavax told our Katherine Ellen Foley that it’s studying its combo vaccine “as both a primary regimen and as a booster shot.” SHAMELESS SELF-PROMOTION — Lauren appeared on Vox’s “Today, Explained” podcast to talk about the pressure on FDA to authorize Covid vaccines for kids under 12. Give it a listen! | | | |   | | | | | | FDA SAYS MORE THAN 5 MILLION E-CIGS MUST BE TAKEN OFF THE MARKET — FDA has ordered 5 million e-cigarette products off the market, the agency said Thursday. These products "failed to provide sufficient evidence" that the benefits to adult smokers, for whom vapes are a less-damaging alternative to traditional tobacco, outweigh the "documented risks to youth." The decision comes as part of FDA’s court-ordered deadline to issue marketing orders for roughly 6.5 million e-cigarette products represented in premarket tobacco applications. The agency said it has gone through roughly 93 percent of applications, and that most pending applications are in the "final stages of review." An industry reshaped: The majority of the companies that received market denial orders were small and medium-sized businesses that will be severely financially impacted by the agency’s decision. “It was a bloodbath,” said Amanda Wheeler, the president of the American Vapor Manufacturers Association, of the market denial orders issued recently. Big players missing: The agency surprised many observers by delaying its verdict on the industry's largest players, after saying for months that its review process would give priority to firms by market share. Companies including Juul, Vuse and NJOY still have applications under review. | | | | 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 . | | | | | | | | HOUSE DEMS UNVEIL HEALTH PORTION OF $3.5 TRILLION MEGA-BILL — House Energy and Commerce Committee Democrats released the health care planks — including contentious drug pricing legislation — they plan to include in the $3.5 trillion budget reconciliation package being assembled on Capitol Hill, POLITICO’s Alice Miranda Ollstein writes. Democrats will include H.R. 3 in the package, which would empower the federal government to directly negotiate with drug companies over how much Medicare pays for pricy and commonly used prescriptions. The committee print for the reconciliation package would only partially fund Biden administration proposals for pandemic preparedness funds and a new research agency to work on chronic diseases at $15 billion and $3.5 billion, respectively (compared to the administration’s requested $65 billion and $6.5 billion). The panel, along with the tax-writing Ways and Means Committee, will mark up the health sections of the bill, setting it up for a floor vote in late September. One big happy family: Alice and Heather Caygle dove into the intraparty fighting that’s already spilling into public view, as Democrats debate beefing up Obamacare programs versus pursuing progressives’ “Medicare for All” aspirations. HHS BACKS DIRECT GOVERNMENT DRUG PRICE NEGOTIATIONS — A new Biden administration plan aimed at lowering prescription drug prices endorses giving the government sweeping power to directly negotiate the cost of medicines, calling it one of the key steps Congress could take to make drugs “more affordable and equitable” for all Americans, POLITICO’s Adam Cancryn reports. The Department of Health and Human Services plan largely backs congressional Democrats’ efforts in the reconciliation proposal and mirrors legislative options that House and Senate lawmakers have floated in recent years: capping out-of-pocket costs in Medicare Part D, limiting how quickly pharmaceutical companies can hike prices on existing drugs and banning agreements aimed at blocking generic competition to brand-name drugs. PHARMA LOBBY PANS DEMS’ DRUG PRICING PLANS — PhRMA head Stephen Ubl called the Biden administration's plan to lower drug prices "a laundry list of old partisan ideas" that falls short of its goal, POLITICO’s Megan R. Wilson reports. He and pharmaceutical company executives criticized Democrats’ efforts to rein in prices earlier this week, focusing on H.R. 3. Merck’s Ken Frazier said big companies like his would survive if the legislation were to pass, but they’d conduct “significantly less research” into the riskiest prospective treatments. | | | FDA TO HOST OPIOID CRISIS WORKSHOP — The agency will hold a two-day virtual meeting, beginning Oct. 13, to weigh whether it should institute mandatory prescriber education on dispensing opioids. “In light of the many available education programs and the lack of a nationwide standard, FDA is exploring the value of a single source for education on the appropriate use of opioids, on the risks of opioid abuse and misuse, and on the treatment of opioid use disorder to address multiple needs and reduce the burden on prescribers,” the agency said in a notice published this week. FDA, FTC CALL OUT DUBIOUS DIABETES DRUGS — FDA and the Federal Trade Commission teamed up this week to warn 10 companies they may soon face legal action over the sale of dubious diabetes treatments amid record-high insulin prices, warning that the products are unapproved and misbranded. “Out-of-control insulin prices are driving Americans to turn to questionable products rather than proven treatments,” said Samuel Levine, acting director of the FTC’s Bureau of Consumer Protection. | | | DME INDUSTRY LAUNCHING E-PRESCRIPTION COMPANY — Several Durable Medical Equipment groups announced Wednesday they are launching DMEscripts — an e-prescribing company — in an effort to speed adoption of electronic ordering applications by suppliers. | | | Former FDA Commissioner Stephen Hahn is interim chief medical officer at YourBio Health, which sells at-home Covid antibody blood tests. Carolina Wirth has joined Faegre Drinker‘s FDA-regulated products practice in D.C. She served as regulatory counsel in the Office of Regulatory Policy within FDA’s Center for Drug Evaluation and Research earlier in her career. Moderna is looking for a D.C. lobbyist. Johnson & Johnson is hiring two public affairs specialists to tout Janssen’s Covid, RSV and HIV vaccine work (based in central Jersey, not far from Lauren’s Pennsylvania hometown!). | | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA. What issues cause the FDA to reject New Dietary Ingredient Notifications? – Under the terms of the Dietary Supplement Health and Education Act of 1994, any dietary ingredient intended for use in a dietary supplement that was not marketed by the time of the law’s passage is considered a New Dietary Ingredient, or NDI, and needs to undergo FDA review. AgencyIQ reviewed all available NDI Notification responses by the FDA going back to 2017 (n=231) and found that issues related to product quality, data deficiencies or safety resulted in the rejection of 54 of those notification requests. Fifty of those letters referenced data concerns (such as a lack of data about an ingredient’s history of use) and 42 referenced quality problems. A majority (39) included references to both issues. The most common issues referenced by the agency were those related to establishing an NDI’s identity (41). AgencyIQ s can read the full analysis here. | | | The Baltimore Sun reports that Maryland is pushing ahead with plans to allow Covid-19 booster shots for many older adults living in settings like nursing homes despite a lack of formal federal advice if a wide swath of the elderly should get the third doses. | | | FDA posted updated Q&A guidance on the development of abbreviated new drug applications during the Covid-19 pandemic on Wednesday. | | 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 | | | | |  |
