FDA’s coronavirus vaccine meeting goes to YouTube

With Zachary Brennan and David Lim

— FDA will air adcomm on YouTube and release its remaining documents today.

Government watchdog probes interference claims at CDC and FDA.

Biden mulls German model to lower drug prices, a spooky prospect for pharma.

It’s Tuesday, welcome back to Prescription Pulse. As the intensifying coronavirus pandemic is expected to worsen in the fall and winter, we’re continuing to track the ability of hospitals, nursing homes and other care providers to manage the crisis. Are you a health care worker? Tell us what you’re seeing with this quick survey. As always, send pharma tips and news to [email protected] or @owermohle. Loop in David Lim ([email protected] or @davidalim) and Zachary Brennan ([email protected] or @ZacharyBrennan)!

LET’S TALK ABOUT INEQUALITIES IN HEALTH CARE: We’re hosting an Oct. 29 virtual town hall on the policies and public health solutions needed to solve racial inequalities in the U.S. health care system – and we want your stories to help shape that conversation. Submit a 45-second video sharing your thoughts and we may feature it in our town hall and invite you to join our private Zoom discussion afterward to continue the conversation.

FDA AIRING VAX ADCOMM ON YOUTUBE — FDA will air its hotly anticipated coronavirus vaccine advisory committee on YouTube this week amid expectations that it could be viewed by tens of thousands of people.

“We’re anticipating significant public interest, & we’ll be live streaming the meeting over YouTube,” Commissioner Stephen Hahn tweeted Monday. “Meeting topics include studies needed to support authorization or approval, post-marketing safety studies needed following an approval, and what would be necessary for ongoing, active safety follow up after issuing an emergency use authorization for a [Covid-19] vaccine.”

Background: Although its decisions aren’t binding, the Vaccines and Related Biological Products Advisory Committee has taken on an outsized importance leading up to its first coronavirus meeting on Oct. 22. President Donald Trump has repeatedly said that a shot could come before Election Day — an impossible goal now — and has accused the FDA of standing in the way of progress for political reasons.

The FDA is preparing for tens of thousands of people to tune into the panel’s initial meeting, a departure from past practice for similar advisory committees attended largely in person by D.C.-area experts and academics. Such meetings normally attract an online audience of just 100 to 1,500 people, an FDA spokesperson said.

What’s next: FDA will post the full agenda and roster two days before the meeting (so, today). At least three regular committee members will be recused because of potential conflicts; several pharmaceutical companies are also expected to present.

WEDNESDAY: Several nonprofits are holding a rally and protest outside of HHS headquarters in D.C. on the need for a Covid-19 vaccine that is free and accessible to all worldwide.

GOVERNMENT WATCHDOG PROBES INTERFERENCE CLAIMS The Government Accountability Office will investigate whether Trump administration officials improperly interfered with the coronavirus response at the Centers for Disease Control and Prevention and the Food and Drug Administration, Senate Democrats announced Monday.

They demanded the probe a week ago, citing reports from POLITICO and other outlets that detailed how political appointees sought to steer the science agencies’ policies and communications to match Trump’s efforts to minimize the pandemic.

Those included Dan Diamond’s reports that HHS officials sought to tamper with CDC’s weekly science reports as well as disputes over control of lab-developed tests, reported by Adam Cancryn and me.

A GAO official confirmed to Dan that an audit would start as soon as possible. However, the agency cautioned in its letter to Warren that it would not be able to begin its probe for about three months.

ORASURE GETS AUTHORIZATION FOR AT-HOME SAMPLE COLLECTION — OraSure Technologies announced Monday that subsidiary DNA Genotek won emergency use authorization for an at-home sample collection protocol that a health care provider doesn’t need to supervise — a first, according to OraSure CEO Stephen Tang.

“This is significant from a number of perspectives, it certainly clears a pathway for our product to be used explicitly in molecular tests that need to have collection,” Tang said. There is currently still no FDA-authorized over-the-counter Covid-19 test individuals can perform without a prescription from a health provider.

It is unclear how many of the collection kits can be manufactured, but Tang said the company is working to double all sample collection products from 35 million per year currently to around 70 million by the third quarter of 2021.

BIDEN MULLS GERMAN MODEL TO LOWER DRUG PRICES Presidential candidate Joe Biden floated an idea last week that may scare some pharma companies — using Germany as a model for lowering U.S. drug prices.

Germany employs an independent institute, known as IQWiG, to assess the benefits of new therapies against already marketed drugs, Zachary Brennan writes. Prices for new drugs also have to be justified. Such an institute in the U.S. could crack down against drugs that come to market with a high price tag and offer little value over current treatments.

But crucial details in Biden’s plan are still missing, according to Bernstein biotech analyst Ronny Gal, including how Congress might intervene in setting prices and whether the U.S. will set a ceiling price that negotiated discounts can’t exceed, either in commercial discount negotiations or federal programs such as Medicaid.

Biden is also likely setting himself up for the same sort of “socialist price control” critiques thrown at other efforts to better negotiate drug prices at the federal level. “However, it is much better than benchmarking international prices (IPI) and if this is the starting position of the democratic front runner ahead of the election ahead of negotiations in Congress… it certainly could have been worse,” Gal writes.

FDA-RELATED CONGRESSIONAL COMMITTEES TO SEE FACE-LIFT — Retirements in the Senate and House committees that deal with the FDA’s budget and related legislation will mean a new set of leaders overseeing the agency, Zachary writes.

The House side will see at least 10 vacancies — four Democrats and six Republicans — on the Energy and Commerce Committee, which deals with FDA- and health-related legislation. Those retirements will also leave E&C’s health subcommittee with at least six vacancies — three Democrats, three Republicans — according to the Alliance for a Stronger FDA.

In addition, House Appropriations Chair Nita Lowey (D-N.Y.) is retiring, and Democrats looking to take her place include Ohio’s Marcy Kaptur, a former member of the FDA appropriations subcommittee; Connecticut’s Rosa DeLauro, a previous chair of the FDA subcommittee; and Florida’s Debbie Wasserman Schultz.

On the Senate side, the Health, Education, Labor and Pensions Committee, which can vet new FDA commissioners, will see three senior Republican retirements — Chair Lamar Alexander of Tennessee, Kansan Pat Roberts and Wyoming’s Mike Enzi. Two other Senate HELP Republicans, Susan Collins of Maine and Georgia’s Kelly Loeffler, and Democrat Doug Jones of Alabama are facing close election races.

HHS LAWYER: DRUG CARDS COULD VIOLATE ELECTION LAW — Trump’s plan to give seniors $200 discount cards to buy prescription drugs could violate election law, the health department’s top lawyer is warning in an internal memo described to Dan by three officials with knowledge of the concerns.

Robert Charrow’s objection, coupled with his advice to seek approval from the Department of Justice, is a significant blow to Trump’s hope to promote the hastily devised plan before Election Day, Dan writes.

Charrow cautioned health officials that moving forward with the proposed $7.9 billion plan — which would be paid for by dipping into one of Medicare’s trust funds, and which senior Trump appointees had hoped to tout in letters sent to millions of seniors this week — would spark concerns about inappropriately using federal funds so close to the election.

He instructed administration officials to seek guidance from the DOJ’s public integrity section, which deals with election crimes, before moving forward with the drug discount plan. That has further stalled the plan as the health department waits for DOJ review, said two officials.

COMPANY REQUESTS FDA HEARING RATHER THAN PULL BIRTH DRUG — Amag Pharmaceuticals recently requested a formal hearing to officially review the FDA’s call for the withdrawal of its drug to reduce early births.

FDA earlier this month called on the company to remove the drug, known as Makena, and its generic versions from the market after a post-approval trial failed to show that it helped babies or reduced the risk of an early birth.

But Amag is standing by its drug, noting, “We believe it is in the best interest of these high-risk pregnant patients to allow their obstetrical provider to determine whether to use Makena, following the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) guidelines, as well as their own long-standing clinical experience.”

CVS BOOSTS HIRING AHEAD OF WINTER SEASON — The pharmacy chain announced Monday that it’s recruiting 15,000 employees in anticipation of the fall and winter months “when the incidences of COVID-19 and the flu are expected to increase.”

More than 10,000 of the new roles are for pharmacy technicians, CVS said in a statement: “[P]harmacy technicians can help fill the urgent need to safely and quickly scale distribution of a vaccine and extend the capacity of the health care workforce to address the pandemic.”

NY BEGINS VAX DISTRO PLAN, LOBS QUESTIONS AT FEDS — New York Gov. Andrew Cuomo has begun to outline plans for how New York might distribute a vaccine once it becomes available, POLITICO New York’s Bill Mahoney reports.

Except: Cuomo said Sunday that his draft is based on “sketchy information” due to a lack of coordination by the federal government. So it’s an instance of “doing the best with what we can” with the information that’s currently available.

Cuomo’s plan is similar to the framework recommended by the National Academies of Sciences, Engineering, and Medicine, which instructs governments to prioritize high-risk patients and long-term care workers followed by other at-risk people and teachers, first responders and public health workers.

What’s next: Cuomo also announced that the National Governors Association, which he heads, will release a letter asking 36 questions about national plans for which states will need answers in order to develop their strategies.

WHO STUDY ROCKS REMDESIVIR RESULTS — The World Health Organization study suggesting Gilead’s antiviral drug remdesivir had little or no effect at reducing hospitalization length or mortality has caused quite a stir, write Politico Europe’s Helen Collis and Jillian Deutsch along with our new Global Pulse author (and Europe transplant) Carmen Paun.

The U.S. drugmaker is questioning the WHO’s findings, arguing that the data appeared inconsistent; that the findings were premature and not peer reviewed; and that other studies had validated the benefits of remdesivir — one of the drugs that Trump touts as having helped him overcome Covid-19.

WHO’s defense: The WHO’s chief scientist, Soumya Swaminathan, on Friday defended the results of the Solidarity trial results. “This is now the largest trial in the world and has the largest body of evidence for remdesivir,” she said. “So we had over 5,000 patients, randomized — either remdesivir or the standard of care.”

When did Gilead know? The trial results came a week after the EU agreed to a billion-euro deal with Gilead to supply half-a-million doses. But making matters worse for the drugmaker, new allegations came out over the weekend that the company knew of these results before signing the deal with Brussels.

…WHO officials cited in the Financial Times say they told Gilead about the trial results at least two weeks before the company signed the deal with the EU. Gilead said the WHO provided a “heavily redacted” manuscript in late September and that the company has yet to receive the “underlying datasets or statistical analysis plan necessary to validate the results.”

Kristen O’Brien has joined McDermott+ Consulting as a vice president. She was previously a principal in OFW Law’s health industry policy and regulatory practice.

— Eastman Kodak CEO Jim Continenza said the company is still working to make drug ingredients and defended its massive U.S. government loan during a Wall Street Journal event Monday, Rachel Levy reported.

— Trump adviser and close ally Scott Atlas has routinely challenged doctors in top federal roles including Stephen Hahn, NIAID Director Anthony Fauci, CDC Director Robert Redfield and coronavirus task force leader Deborah Birx, The Washington Post’s Yasmeen Abutaleb, Philip Rucker, Josh Dawsey and Robert Costa reported.

CMS issued a proposed decision memo Friday stating the agency believes there is adequate evidence to cover blood-based biomarker tests for colorectal cancer screening. Comments are due on the memo 30 days from Oct. 16.

FDA and industry began discussing the next prescription drug user fee reauthorization, known as PDUFA VII, which will run from 2023 to 2027.

The FDA on Monday marked the anniversary of a blueprint that outlined how it planned to modernize its operations and technology. Top officials Principal Deputy Commissioner Amy Abernethy and Chief Technology Officer Vid Desai discussed it in a blog post.

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