A note from 340B Report CEO and Publisher Ted Slafsky: Today’s issue continues our ongoing series of articles by 340B Report sponsors that draw on their deep expertise. Click on the button below or reach me at ted.slafsky@340BReport.com to learn more about the benefits of becoming a sponsor.
U.S. House Speaker Nancy Pelosi (D-Calif.) announces the introduction of the HEROES Act on May 12. The $3 trillion bill excludes waivers for 340B hospitals supported by more than 100 members of Congress. | (Source: C-SPAN)
340B Hospital Provisions Left Out of Latest COVID-19 Bill
The new $3 trillion COVID-19 relief bill that House Democrats unveiled this week excludes language that more than 100 members of Congress want to protect hospitals from losing their eligibility for 340B drug discounts during the pandemic. Those lawmakers also want Congress’ to let 340B hospitals use group purchasing organizations during the emergency to buy covered outpatient drugs.
House Democrats introduced their HEROES Act on May 12, four days after Reps. Doris Matsui (D-Calif.), Chris Stewart (R-Utah), and 121 colleagues sent a letter to House and Senate party leaders asking them to attach the requested 340B provisions to “any future supplemental relief bill.”
The Congressional Progressive Caucus separately has asked Speaker Nancy Pelosi (D-Calif.) and Majority Leader Steny Hoyer (D-Md.) to postpone a full House vote on the HEROES bill until next week to permit discussion of “any amendments that might be needed.” Liberal Democrats reportedly are unhappy that the bill doesn’t address controlling prescription drug prices in general and COVID-19 drug and vaccine prices in particular. New survey research suggests the public agrees about the latter. According to a commentary in STAT this morning, a late April survey of 1,000 U.S. adults found that “78 percent said the U.S. government should regulate the price of COVID-19 treatments, and 53 percent said that drug companies shouldn’t make profits at all from COVID-19 therapies.”
The delayed vote on the HEROES Act could give the 340B letter’s signers another shot at getting their language into the bill.
Even if they succeed, though, there’s little chance the HEROES Act will become law in its present form. Democrats drafted it without Republican input and the GOP has dismissed the bill. For now, there’s little sign of urgency among congressional Republicans about passing another pandemic relief bill.
The 1,815-page HEROES Act includes:
Another $100 billion in grants to hospitals and other health care providers for expenses and lost revenue attributable to COVID-19
$75 billion for COVID-19 testing and contact tracing
$7.6 billion for health centers
$10 million for Ryan White HIV/AIDS clinics
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340B Coalition Turns Summer Conference into 5-Day Virtual Meeting
The 340B Coalition announced yesterday that its summer conference will be held as a virtual event, spread out over five days during the last two weeks of July. The live summer event was scheduled for July 20-22 in Washington, D.C. “This decision is necessary to protect the safety and health of our attendees, exhibitors, speakers, and staff, which is our highest priority,” the coalition says in an announcement sent yesterday. Last year’s summer conference had more than 1,700 attendees and 65 exhibitors.
Registration fees for the virtual event are 30 percent less than what the coalition was charging for the live version. Organizers say the virtual conference will provide “multiple interactive opportunities to network with 340B professionals and exhibitors.” The agenda page refers to a “virtual exhibit hall & attendee lounge” where attendees can “talk directly with [exhibitors] in their virtual booth” and “catch up with your colleagues from around the country.”
During the week of July 19-25 sessions will be held:
Monday July 20 noon to 3:30 p.m. EDT (pre-conference workshops)
Tuesday July 21 noon to 4:00 p.m. EDT
Wednesday July 22 noon to 4:00 p.m. EDT (additional special roundtables 10:00 to 11:00 a.m.)
During the week of July 26-Aug. 1 sessions will be held:
Tuesday July 28 noon to 4:00 p.m. EDT
Wednesday July 29 noon to 2:00 p.m. (additional special roundtables 10:00 to 11:00 a.m.)
Apexus, the 340B prime vendor, will hold the 340B University program originally scheduled for July 19 before the coalition conference as a virtual event, a Health Resources and Services Administration (HRSA) spokesperson said today.
“The health and safety of all participants in the 340B University live program is a priority, especially during this time of social distancing due to the COVID-19 pandemic,” HRSA said. “The 340B University program will be offered virtually adjacent to 340B Coalition July 2020 Summer Conference. The 340B Prime Vendor Program is in the process of developing a 340B University live virtual program and in the coming weeks, registration for the 340B University virtual education sessions will be announced through the HRSA 340B Prime Vendor Program website at www.340Bpvp.com/education, via an email to Prime Vendor participants, and to 340B Coalition Summer Conference attendees.”
Will COVID-19 Improve Pharma’s Image and What Does it Mean for 340B?
Drug company executives and trade groups might hope that the industry’s response to the COVID-19 pandemic will help improve the industry’s public image. They shouldn’t get their hopes up too high, says 340B Report Publisher and CEO Ted Slafsky in his latest column for Pharmaceutical Strategies Group, a 340B Report sponsor.
“I expect Americans will continue to be upset about high drug prices,” Slafsky says, citing recent survey findings about the high priority voters place on lowering drug costs and the numbers of adults who can’t afford their medicine or have had a friend or family member die after not being able to pay for treatment. “As we face the worst unemployment crisis since the Great Depression, combined with a dramatic increase in the uninsured and underinsured, concerns over affordable health care will only become more acute,” he says.
“What does this mean for 340B stakeholders? In the short term, this could harden the administration’s position on Medicare Part B reimbursement cuts to hospitals,” Slafsky continues, noting that the administration has touted cuts as one of its “big wins on drug pricing.” (Tomorrow is the deadline for hospitals to complete CMS’s related survey of 340B drug acquisition costs.)
“While many of us realize that these cuts are misguided and are actually harmful to patient care, we should not expect a reversal,” he says. At the same time, Slafsky says he is heartened by continuing strong bipartisan support for 340B in both the U.S. House and Senate. “The 340B provider community is now receiving the heroic status that they have always deserved,” he concludes. “Your efforts to serve our most vulnerable during this pandemic will leave an indelible mark that will have long-term benefits for patients and for the country as a whole.”
Celgene Limits Cancer Drug Purchases Due to Shortage
Celgene, a Bristol-Myers Squibb subsidiary, is limiting purchases of its cancer treatment Vidaza due to increased demand, the company announced yesterday in a public notice on the Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA) website. “Limitations on purchasing of Vidaza in the United States will be proportional and non-discriminatory for all customers, including 340B covered entities,” the notice states. The company said it expects the allocation system to remain in place for the rest of the year.
BIO Appoints New President and CEO
Biotechnology Innovation Organization (BIO), the biotechnology and biopharmaceutical trade association, announced this morning that Michelle McMurray-Heath, a former senior FDA official during the Obama administration, is succeeding former U.S. Rep Jim Greenwood (R-Pa.) as the association’s president and CEO.
According to BIO’s press release, McMurry-Heath has been a senior executive at Johnson & Johnson since 2014, serving most recently as Vice President of External Innovation and Global Leader for Regulatory Science. Janssen, J&J’s pharmaceutical manufacturing subsidiary, is a member of drug industry-led advocacy group AIR 340B, which wants a narrower 340B patient definition, tighter hospital eligibility criteria, and restrictions on 340B contract pharmacy.
House Committee Chairs Wants Answers About Remdesivir Distribution
Two U.S. House health subcommittee leaders have asked Health and Human Services (HHS) Secretary Alex Azar to disclose how HHS decides which states get how many doses of remdesivir, the investigational drug being used on an emergency basis to hasten recovery from infection with the virus that causes COVID-19.
Rep. Lloyd Doggett (D-Texas), chair of the Ways and Means health subcommittee, and Rep. Rosa DeLauro, chair of the Appropriations health subcommittee, asked Azar for the information in a May 13 letter. The pair earlier asked Azar in an April 30 letter for information on the extent to which taxpayers financed remdesivir’s development.
Remdesivir has had a rough rollout. First, its manufacturer, Gilead, obtained an orphan designation for the drug, despite projections that 96 million in the United States could be infected with the SARS-CoV-2 virus. Gilead asked for the designation to be rescinded in the wake of a public outcry. Gilead then announced it was donating its entire supply of 1.5 million vials of the drug globally after the FDA authorized remdesivir’s emergency use on May 1, with 607,000 vial committed to the United States—enough for 78,000 patients only. On May 5, HHS sent about 35,000 vials to hospitals in seven states. It’s still unclear why some lightly affected hospitals got shipments while hard-hit ones got none. On May 9, HHS announced that, moving forward, state health departments would take over allocating doses to hospitals.
In their latest letter to Azar, Doggett and DeLauro said, “HHS distribution of remdesivir seems akin to winning the lottery—a random stroke of luck rather than a medically-informed decision.” In addition to asking Azar for HHS’s formulas for allocating remdesivir to states, the lawmakers asked for the guidance HHS is giving states about allocating doses to hospitals. They also want to know how and why the United States got only 40 percent of Gilead’s 1.5 million vials, whether the federal government has agreements with Gilead for future doses and at what prices, and what plans the government has for building or retrofitting facilities to make more remdesivir.