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Presented by Genentech: 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 Genentech | With Katherine Ellen Foley and Emily Martin. | | | — FDA will add a warning about rare heart inflammation to fact sheets for Pfizer’s and Moderna’s Covid-19 vaccines. — House Democrats want to send nearly $3.5 billion in appropriations to FDA in fiscal 2022. — The medical device industry is lobbying Congress to codify automatic Medicare coverage of breakthrough medical devices that get marketing authorization from FDA. | | | | A message from Genentech: A person’s health shouldn’t be determined by their gender, race, sexual orientation, socioeconomic background or zip code. But data show these factors significantly influence access to care and health outcomes. Read more about how Genentech is challenging ourselves, and others, to pursue bold solutions rooted in population science, inclusive research, and philanthropy to realize the promise of personalized healthcare and optimized treatment outcomes for all. | | | It’s FRIDAY, welcome back to Prescription Pulse. We wish D.C. weather would stay this nice the rest of the summer. Be sure to send tips to David Lim (dlim@politico.com or @davidalim), Lauren Gardner ( lgardner@politico.com or @Gardner_LM) and Katherine Ellen Foley (kfoley@politico.com or @katherineefoley). | | | FDA TO ADD MYOCARDITIS WARNING TO mRNA SHOTS — Doran Fink, deputy director of FDA's vaccines division, told the CDC’s outside vaccine advisers on Wednesday that the agency was preparing to “quickly” add the warning to the mRNA vaccines’ fact sheets, after hearing the panel confirm there’s a “likely association” between the shots and cases of myocarditis and pericarditis in recipients. While the cases are rare compared to the number of doses administered, the preponderance of cases has been observed in men under 30. An FDA spokesperson told Rx Pulse that the agency would provide more information soon. The issue has taken on greater urgency as vaccine makers study immunizing younger populations, vaccination uptake continues to dwindle and the dangerous Delta variant spreads throughout regions of the country. Amid all those factors, the vaccine advisory panel — plus a coalition of federal and private public health officials — clearly stated Wednesday that the Covid shots’ benefits greatly outweigh the potential risks. TO BOOST OR NOT TO BOOST — Another issue the committee weighed was what data is needed to decide when and whether the population needs Covid vaccine booster doses, something officials emphasized has yet to be determined (despite biotech CEOs regularly opining about the timelines for boosters). The CDC’s Sara Oliver said the agency’s working group on the issue doesn’t expect to make a recommendation until declining vaccine effectiveness can be demonstrated, or if a variant evades the shot’s protection. Other questions public health officials must study is whether the vaccine cocktails must be reworked or if third doses are sufficient to offer booster protection, and whether certain populations — like the immunocompromised or long-term care home residents — should be carved out to receive boosters. | | | HOUSE DEMS PROPOSE $3.5B FOR FDA APPROPRIATIONS — The House Appropriations Agriculture-FDA Subcommittee will mark up a draft bill today that would direct nearly $3.5 billion to FDA in fiscal 2022, Lauren writes. The measure would amount to a $257 million boost over current spending and, counting user fees, would total nearly $6.3 billion for the agency. The proposal generally tracks with the Biden administration’s budget request for FDA, though it wouldn’t provide the nearly $100 million boost to the agency’s tobacco center sought by the White House. The full committee will mark up the bill Wednesday. DEVICE INDUSTRY LOOKS TO CONGRESS TO CODIFY MCIT — Weeks after CMS announced it is again delaying implementation of a controversial Trump-era plan to automatically grant breakthrough devices four years of Medicare coverage, the device industry is touting two legislative efforts to codify the plan into law. On Wednesday a bipartisan collection of House lawmakers introduced H.R. 4043 , standalone legislation that would grant the four years of Medicare coverage to breakthrough devices and require CMS to make a permanent coverage determination. And similar text is included in Reps. Fred Upton (R-Mich.) and Diana DeGette's (D-Colo.) recently released 21st Century Cures 2.0 discussion draft. AdvaMed and the Medical Device Manufacturers Association — device trade groups that have heavily lobbied for the policy — applauded the new legislative efforts. | | | |   | | | LAWMAKERS BRING BACK MEDICAL TEST REGS OVERHAUL — A bipartisan, bicameral group reintroduced tweaked legislation Thursday that would overhaul how the FDA oversees laboratory-developed tests and diagnostics. Reps. Larry Bucshon (R-Ind.) and DeGette are backing the bill in the House, with Sens. Michael Bennet (D-Colo.) and Richard Burr (R-N.C.) sponsoring the Senate version. LAWMAKERS PRESS WOODCOCK FOR TOUGHER FDA RULES ON E-CIGS — Acting FDA Commissioner Janet Woodcock dodged lawmakers’ requests for confirmation that the agency would ban all flavors of e-cigarettes except tobacco at a house oversight hearing on Wednesday. Though Woodcock agreed that youth vaping and nicotine addiction remains a major problem in the U.S., she avoided taking a definitive stance on the grounds that the agency is still reviewing nearly 6.5 million premarket tobacco applications for items including e-cigarettes, cigars, hookah tobacco and certain nicotine gels. FDA has until September to make a decision, a deadline the agency has hinted it will likely miss. | | | FDA DESIGNATES LILLY’S ALZHEIMER’S CANDIDATE A BREAKTHROUGH THERAPY — Eli Lilly’s Alzheimer’s drug candidate, donanemab, received the FDA’s designation as a breakthrough therapy. Lilly announced Thursday it intends to apply for accelerated approval for donanemab later this year, a decision that comes shortly after FDA greenlit Biogen’s Aduhelm under the pathway. Donanemab is in late-stage clinical trials; it’s a monoclonal antibody that targets the plaque build-ups that are characteristic of Alzheimer’s disease. Results of its Phase II clinical trial showed that it slowed the progression of the disease compared to the placebo. However, like Aduhelm, it also doesn’t appear to stop or reverse the disease. TECAN AGREES TO BUY PARAMIT FOR $1B — Lab equipment manufacturer Tecan announced Wednesday it agreed to acquire medical device maker Paramit Corporation for $1 billion. | | | | SUBSCRIBE TO WEST WING PLAYBOOK: Add West Wing Playbook to keep up with the power players, latest policy developments and intriguing whispers percolating inside the West Wing and across the highest levels of the Cabinet. For buzzy nuggets and details you won't find anywhere else, subscribe today. | | | | | | | | SENATE DEMOCRAT INTRODUCES DRUG PRICE REFORM PLAN — Senate Finance Chair Ron Wyden (D-Ore.) on Tuesday outlined a proposal for a mechanism to lower prescription drug prices, POLITICO’s Alice Miranda Ollstein reports . Drug pricing has been a popular issue among both Democratic and Republican lawmakers, though talks have stalled amid partisan disagreements. Wyden’s plans come as other lawmakers, including Senate Budget Chair Bernie Sanders (I-Vt.), are drafting additional health care reform policies that can be folded into the infrastructure package. | 
Photo by Anna Moneymaker - Pool/Getty Images | DURBIN, GRASSLEY, KING WANT DRUG ADS TO DISCLOSE LIST PRICES — Sens. Chuck Grassley (R-Iowa), Dick Durbin (D-Ill.) and Angus King (I-Maine) on Thursday reintroduced legislation that would require direct-to-consumer advertisements for prescription drugs and biologics to contain a disclosure of their list price. | | | STENZEL: FDA OPEN TO INTERNATIONAL STUDIES FOR COVID TESTS — FDA Diagnostics Director Tim Stenzel on Wednesday told Covid-19 test developers the agency is “now very open to the use of international studies” to collect data for test submissions due to lower levels of Covid-19 infections in the U.S. “This is all in an effort to get actual positive patient samples for the validation, which is always preferable,” Stenzel said on the industry call. ADVAMED ASKS BIDEN ADMIN TO ASSIST TRANSPORT OF MEDICAL SUPPLIES — AdvaMed this week asked President Joe Biden to “make the transport of medical supplies and equipment a top priority” amid a shipping crunch at ports and insufficient trucking capacity. “I don't think we're asking them to invoke the Defense Production Act or rated orders,” Abby Pratt, AdvaMed senior vice president of global strategy, told POLITICO. “We're saying more holistically as they're looking at these issues, not just our sector, but other sectors, to think about the importance of medical technologies.” | | | EU DRUG REGULATOR: MIXING VACCINES SAFE BASED ON EARLY DATA — The European Medicines Agency said there are “good scientific grounds” to suggest that mixing Covid-19 vaccines is safe and effective since the approved shots all work in a similar way, POLITICO EU’s Helen Collis and Jillian Deutsch report. The regulator also pointed to early data from Spain and Germany that suggests “a satisfactory immune response and no safety concerns.” Results have so far shown that mild reactions such as headaches and flu-like symptoms are more common with mixed combinations. ITALY’S RIGHT SEIZES ON TEEN’S DEATH LINKED TO ASTRAZENECA SHOT — Italian officials are calling on the national health ministry to issue precise guidance on “open days,” meant to use up unused vaccines, while the right attacks the government for incompetence after the death of a teenager who developed blood clots, POLITICO EU’s Hannah Roberts and Carlo Martuscelli report. | | | CDC PANEL UPDATES FLU SHOT RECS — The CDC’s vaccine advisory committee voted unanimously Thursday to update its guidance for the 2021-2022 flu season to recommend that adults who aren’t pregnant avoid getting vaccinated against the virus in July and August, amid concerns of waning immunity among older patients. The panel also approved the flu vaccine compositions for the season. NIH TO STUDY PREGNANCY COVID SHOTS — NIH has launched an observational study of people vaccinated against Covid during pregnancy or in the two months postpartum to evaluate their antibody responses, including the extent to which protection is passed on to children. | | | | TUNE IN TO DISPATCH+ ON APPLE PODCASTS : POLITICO Dispatch, our daily podcast that cuts through the news clutter and keeps you up to speed on the most important developments of the moment, is expanding. In collaboration with the new Apple Podcasts Subscription platform, Dispatch+ launches this week! This new podcast gives premium Dispatch+ s exclusive bonus weekly reporting and analysis from POLITICO's newsroom. Don't miss out, subscribe and listen to Dispatch+ on Apple Podcasts. | | | | | | | | Courtney Paul is now a senior executive speechwriter at Mayo Clinic. She previously worked as manager of public affairs at AdvaMed. Sarah Arbes is now vice president for federal affairs and alliance development at biotech company bluebird bio. She is HHS’ former assistant secretary for legislation. Sara Lonardo is now senior director of communications at Families USA. She previously was assistant director of communications for national media at the Service Employees International Union and communications director for Rep. Rosa DeLauro (D-Conn.). Peter Bach announced Wednesday he is joining liquid biopsy startup Delfi Diagnostics as the company’s chief medical adviser. | | | Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for the FDA. Reps. Degette and Upton this week unveiled a discussion draft of their 21st Century Cures 2.0 proposal. The document contains dozens of changes that would affect the life sciences industry, including proposals to increase clinical trial diversity, require the collection of patient experience data, promote the use of novel trial designs, plan for future cell and gene therapies, and more. AgencyIQ has a lengthy overview of the legislative draft, with a focus on the sections that are most relevant from an FDA perspective. Legislation recently reintroduced by Sen. Braun would establish a provisional approval pathway through which products intended to treat serious or life-threatening conditions could obtain time-limited approvals automatically based on improvements to “important” endpoints. Eligible products could obtain approval more easily but would be subject to enhanced post-marketing obligations (like mandatory patient registries) and other restrictions. AgencyIQ has a lengthy explanation of how the bill would work , including how it would affect product approvals at the FDA. | | | The Trump White House pushed HHS and FDA to cut corners to speedily grant a compassionate use exception for then-experimental Covid-19 treatments for the former president last year, The Washington Post reports. Acting FDA commissioner Janet Woodcock publicly defended Biogen’s controversial Alzheimer’s drug Aduhelm, saying it “has a lot more supportive data” than many other drugs that have won accelerated approval over the years, Endpoints News reports. Patients, doctors and current and former employees of Modern Vascular allege that the national arterial disease treatment chain pushes unnecessary procedures and treatments onto patients to drive up the insurance money it can collect, Searchlight New Mexico reports. | | | | A message from Genentech: Having a serious illness is challenging enough without having to worry about being able to afford the necessary treatment. The reality is that out-of-pocket costs are a significant concern for many patients and – all too often – can prevent people from getting the care they need. We believe there are opportunities to implement smart solutions that lower costs for patients and the system, while sustaining the large research and development investments necessary to drive the medical breakthroughs that are urgently needed. Learn more about how Genentech is engaging with patients, advocacy groups, providers, payors, other businesses and legislators to explore market-based policy reforms. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |  |
