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Presented by Rare Access Action Project: 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 Rare Access Action Project | With Katherine Ellen Foley | | | — Seventy percent of American adults have received at least one dose of a Covid-19 vaccine, hitting the Biden administration’s July Fourth goal nearly a month late. — The FDA has awarded a $1.2 million contract to develop procedures and criteria for remote foreign inspection programs. — A Senate panel approved a bill Monday to fund the FDA at $3.4 billion in fiscal 2022. The full Appropriations Committee will consider the bill this week. It’s TUESDAY, welcome back to Prescription Pulse. Anyone else see footage from Lollapalooza and simultaneously feel jealous and terrified? Here’s a picture of Fred Durst to illustrate. 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). | | | | A message from Rare Access Action Project: The $3.5 trillion budget would reduce lifesaving treatments and cures and make it harder for America’s 25 million rare disease patients to have access to the medications they need — and the cures they hope for. There is a better way. Find out more at RareAccessActionProject.org | | | | | | U.S. HITS 70 PERCENT PARTIALLY VAXXED GOAL, 1 MONTH LATER — The seven-day average of newly vaccinated Americans hit its highest point Monday since July Fourth, as administration officials marked reaching the goal of 70 percent with at least one shot. Yet, as of Saturday, the seven-day average of daily new Covid-19 cases hit 72,000, which was an increase of 44 percent from the previous week and higher than last summer’s peak. The good news: Vaccinations protect against most serious disease, hospitalizations and deaths — even as the Delta variant spreads. In newly published data from the U.S., Canada and Israel, both doses of the Pfizer vaccine provided nearly as much protection against the Delta variant as the Alpha variant. However, efficacy appeared to dip in Israel, where the vaccine protected against 64 percent of symptomatic cases. “This is likely due to the fact that Israel has started their vaccination program before other countries,” Anthony Fauci, the head of the National Institute of Allergy and Infectious Diseases, told members of the press. BIDEN READIES SPEECH ON BOOSTING DOMESTIC, GLOBAL VACCINATIONS — President Joe Biden is scheduled to give a speech at 3:45 p.m. ET on his administration’s efforts to bolster vaccinations globally and in the U.S. | | | FDA AWARDS $1.2M CONTRACT FOR REMOTE DRUG INSPECTION PILOT — The FDA is developing procedures to conduct remote, unannounced inspections of foreign drug- manufacturing facilities in an effort to clear the inspections backlog that has developed during the Covid-19 pandemic. At the start of the pandemic, the FDA halted domestic and foreign drug-manufacturing facility inspections due to safety concerns for its employees and travel bans in certain countries. By July 2020, it started conducting some inspections in the U.S. and abroad based on the importance of the products they produced — but it has thousands of inspections to complete by the end of the fiscal year in September 2021. In addition to helping the agency catch up on inspections abroad during the pandemic, standardized remote inspections can make way for surprise inspections of foreign facilities. Foreign manufacturing inspections often require providing advance notice to companies due to the travel of FDA personnel. In March, the Government Accountability Office said that foreign manufacturers routinely fixed facility problems ahead of time when the FDA gave its typical advance notice of up to 12 weeks. FDA EXPANDS AUTHORIZED USE OF COVID TREATMENT — Regulators last week broadened Regeneron’s EUA for its monoclonal antibody treatment for Covid. The cocktail may now be administered to immunocompromised patients anticipated to develop severe Covid after being exposed to the virus, as well as people in institutional settings like prisons or nursing homes where exposure risk is high. | | | | 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. | | | | | | | | SENATE KICKS OFF FDA APPROPS PROCESS — The Senate Agriculture—FDA Appropriations Subcommittee breezily approved its fiscal 2022 spending bill Monday evening, setting the legislation up for full committee markup on Wednesday. The measure would direct $3.4 billion to the FDA — slightly less than what the House recently passed for the agency — including $15 million for facility inspections, according to a summary from the committee. WARREN, KLOBUCHAR, DOGGETT ASK HHS FOR UPDATE ON MARCH-IN REVIEW — Top Democrats asked HHS Secretary Xavier Becerra for an update on whether his department plans to use compulsory licensing of patents or march-in rights to lower prescription drug costs. “Congress should develop and pass drug-pricing legislation. But in the interim, HHS must do more to lower prescription drug costs—and it has preexisting authorities and solutions at its fingertips to do just that,” Sens. Elizabeth Warren (D-Mass.) and Amy Klobuchar (D-Minn.) and Rep. Lloyd Doggett (D-Texas) wrote last week. ANOTHER BREAKTHROUGH CASE IN THE CAPITOL — South Carolina Sen. Lindsey Graham , the Budget Committee’s top Republican, announced Monday afternoon that he tested positive for Covid-19 after experiencing mild flu-like symptoms over the weekend. Graham touted his vaccination status (also positive) in a statement, saying he was “certain” he would be feeling much worse had he not been immunized. Graham’s diagnosis may have ripple effects in the Senate as colleagues consider whether they should get tested as the chamber works to pass a multibillion-dollar infrastructure bill and a $3.5 trillion budget blueprint, which include health-related pay-fors and programs, respectively. | | | |   | | | | | | ARRIVA TO PAY $160M IN SETTLEMENT — Arriva Medical and its parent company Alere agreed to pay $160 million to resolve allegations they violated the False Claims Act by providing a glucometer to new patients without determining their eligibility, the U.S. Department of Justice announced Monday. “Paying illegal inducements to Medicare beneficiaries in the form of free items and routine copayment waivers can result in overutilization and waste taxpayer funds,” Acting Assistant Attorney General Brian Boynton said in a statement. | | | FDA alum Lauren Silvis has completed a five-month stint at HHS, where she was an adviser to the Covid-19 response, our friends at Pulse scooped. She’s currently the senior vice president of external affairs at health technology firm Tempus. | | | GEORGIA AGAIN DELAYS START OF PARTIAL MEDICAID EXPANSION — The start of Georgia’s partial Medicaid expansion program is likely being delayed until the end of the year while the state and the Biden administration hash out a controversial waiver, POLITICO’s Rachel Roubein reports. | | | | 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 . | | | | | | | | GERMANY EYES BOOSTERS, SHOTS FOR MINORS — German health officials Monday approved doling out booster Covid shots to the elderly and immunocompromised beginning in September and recommended vaccinating teenagers, bucking the country’s vaccine regulator as the Delta variant spreads. The European Medicines Agency has already approved the Pfizer and Moderna vaccines for use in children 12 and older. POLISH AUTHORITIES: VACCINATION CENTER FIRE WAS 'ACT OF TERROR' — A fire at a mobile vaccination station Sunday night in the southern Polish town of Zamość was a terrorist incident, Polish Health Minister Adam Niedzielski said Monday. The incident is the latest in a series of anti-vaccine outbursts in Poland, POLITICO’s Wojciech Kość reports, which is struggling to step up its vaccination campaign to thwart a possible fourth wave of cases driven by the Delta variant. | | | FDA labeling for sunscreens — New legislation sponsored by Sens. Marco Rubio (R-Fla.) and Jeff Merkley (D-Ore.) and Reps. Carlos Giménez (R-Fla.) and Ed Case (D-Hawaii) would direct the FDA to establish labeling standards for “reef safe” and “ocean safe” claims that companies could use to market their sunscreen products. The bill, the Reef Safe Act of 2021 , comes in response to environmental concerns that some sunscreen ingredients like oxybenzone and octinoxate can wash off in the water and harm marine life. One state, Hawaii, has already banned sunscreens with some ingredients thought to be unsafe for marine ecosystems. Under the bill, the FDA would join with the Environmental Protection Agency and the National Oceanic and Atmospheric Administration to consider the impacts of sunscreen ingredients on marine life, including fish, coral algae and coastal ecosystems. | | | | A message from Rare Access Action Project: The $3.5 trillion budget would reduce lifesaving treatments and cures. That’s right. Congress is debating a bill that would make it harder for America’s 25 million rare disease patients to have access to the medications and treatments they need — and the cures they hope for.
Rare disease research has made incredible progress in recent years and Congress wants to stop that to pay for pet projects. There is a better way, one that works without forcing European-style price controls. We must protect the innovations that will save vulnerable lives.
Find out more at RareAccessActionProject.org | | | | | | Sanofi is attempting to buy Translate Bio in an effort to break into mRNA technology, Reuters’ Matthias Blamont reports. | | | CMS approved 19 medical technology add-on payments for fiscal year 2022 — including Boston Scientific’s single-use duodenoscope — in its Medicare Hospital Inpatient Prospective Payment System and Long Term Care Hospital Rates Final Rule. FDA is extending the comment period for its draft guidance on enhancing drug distribution security at the package level by 30 days. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
