Timeline for J&J’s vaccine pause grows murkier — U.S. sequencing six percent of Covid-19 cases — FDA rebuts Trump-era proposal to deregulate medical device reviews

By David Lim

Presented by Pharmaceutical Care Management Association

With Lauren Morello and Sarah Owermohle.

— The timeline for the pause on J&J’s vaccine grows murkier.

— U.S. is now sequencing six percent of Covid-19 cases.

— FDA rebuts Trump-era proposal to deregulate review of many medical devices.

It’s Friday, welcome back to Prescription Pulse. Your author is getting his first Covid-19 vaccine shot today! As always, send tips to David Lim (dlim@politico.com or @davidalim).

A message from Pharmaceutical Care Management Association:

The Biden Administration postponed the effective date for the Medicare rebate rule until 2023. Despite the delay, uncertainty remains. The cleanest path forward to avoid disruption to Part D, caused by jarring monthly premium increases, is for Congress to quickly repeal the rebate rule outright.

TIMELINE GROWS FUZZIER FOR DECISION ON J&J VACCINE — The uncertainty around the nationwide pause in the use of Johnson & Johnson’s coronavirus vaccine is growing, after a CDC advisory committee said Wednesday that it did not have enough data to recommend when or how the shot should be used.

Federal health officials called for the temporary halt on Tuesday, in response to six reports of rare but serious blood clots among the roughly 7 million Americans who have received the J&J vaccine. All were women between 18 and 48, and one died. The feds’ concern stems in part from the fact that the condition -- cerebral venous sinus thrombosis -- is worsened by the blood thinner heparin, a standard treatment for more common types of clots.

The administration initially said the pause would likely be days long — and that the government would decide how to go forward based on recommendations from the CDC advisory committee and an FDA investigation. The CDC panel’s call for more data to determine whether the shot caused the clotting incidents has scrambled that timeline, POLITICO’s Sarah Owermohle and Erin Banco report.

Some committee members expressed frustration about the damage that continued uncertainty would do to public confidence and efforts to vaccinate hard-to-reach populations. "We’re in a position where not making a decision is tantamount to making a decision," said Nirav Shah, who directs Maine's public health agency and represents the Association of State and Territorial Health Officials.

The U.S. has enough doses of vaccines from Pfizer and Moderna to meet its goal of vaccinating all adults. But the J&J vaccine -- the only one-shot option available in America -- has been seen as critical for outreach to homeless people, homebound seniors, and other underserved groups.

Meanwhile, in Europe: J&J said Tuesday it would pause its vaccine roll out in the European Union. The European Medicines Agency is set to issue recommendations next week on the use of the vaccine, our POLITICO EU colleague Jillian Deutsch reports.

"While its review is ongoing, EMA remains of the view that the benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects," the agency wrote Wednesday in a press release. Most EU countries have said they plan to go forward with the J&J vaccine.

In a separate announcement, the agency said it will provide more information about who should receive the Oxford/AstraZeneca vaccine, which also has been shadowed by reports of blood clots.

WALENSKY: U.S. SEQUENCING SIX PERCENT OF COVID-19 CASES — Roughly six percent of the country’s 420,000 weekly Covid-19 infections are now being sequenced, according to prepared testimony submitted to Congress by CDC Director Rochelle Walensky.

The CDC has contracts with several commercial labs that are sequencing 15,000 samples per week, a number the health agency is working to nearly double to 25,000. Public health labs, universities and industry groups also are contributing more than 10,000 samples per week.

MERCK PULLS PLUG ON COVID THERAPY — The company is halting trials for potential coronavirus medicine MK-7110, saying that by the time it is ready to file for emergency use authorization, in the first half of 2022, the landscape for Covid-19 treatments and vaccines will have vastly change, POLITICO’s Sarah Owermohle reports.

“Given this timeline and these technical, clinical and regulatory uncertainties, the availability of a number of medicines for patients hospitalized with COVID-19, and the need to concentrate Merck’s resources on accelerating the development and manufacture of the most viable therapeutics and vaccines, Merck has determined to discontinue development of MK-7110,” it said in a statement. The company added that it will devote its energy to producing J&J coronavirus vaccine — currently on pause — and other potential therapies.

It's the latest to narrow the treatment scope. This month, Gilead said it is ending a study for remdesivir, or Veklury, in high-risk but non-hospitalized patients because the multi-day hospital infusion isn’t that practical for that set and it had trouble recruiting patients. Eli Lilly, meanwhile, pulled its single antibody bamlanivimab off the market in favor of an antibody cocktail that fares better against the virus.

NIH ENDS ENROLLMENT IN ACTT-4 STUDY — The National Institute of Allergy and Infectious Diseases announced Thursday it is ending enrollment in an Adaptive Covid-19 Treatment Trial that was attempting to determine whether baricitinib plus remdesivir or dexamethasone plus remdesivir was more effective at treating hospitalized patients.

No safety concerns with either treatment combination, however, an independent data and safety monitoring board found neither was significantly better.

“The trial will remain blinded and investigators will continue monitoring and follow-up of those currently on study treatment per protocol,” NIH said.

NIH AWARDS UP TO $33M FOR SCHOOL TESTING IN UNDERSERVED COMMUNITIES — The NIH’s Rapid Acceleration of Diagnostics Underserved Populations program is awarding up to $33 million for projects at 10 institutions to help establish frequent Covid-19 testing protocols in vulnerable and underserved communities.

“These awards will foster the development of comprehensive programs to meet the challenge of safely returning children to in-person schooling, particularly for children who are vulnerable to COVID-19 or who are at risk for significant disparities in access to testing,” said Diana Bianchi, director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, which is managing the initiative. More awards will be made in the coming months to expand the program to additional locations if funds are available.

A message from Pharmaceutical Care Management Association:

FDA CLAPS BACK — The Biden administration on Thursday withdrew a controversial policy announced during the waning days of President Donald Trump's term that proposed stripping the FDA's ability to review more than 80 types of medical devices.

HHS Secretary Xavier Becerra and acting FDA Commissioner Janet Woodcock said the policy — which would have affected products ranging from sleep assessment devices to surgical isolation gowns — was taken "without adequate scientific support." The Biden health officials argue the Trump-era policy also “contained numerous errors and ambiguities,” such as mismatched product descriptions, codes and regulatory citations, and “is otherwise flawed.”

“We did not find any evidence that HHS consulted with, otherwise involved, or even notified FDA before issuing the Notice,” Becerra and Woodcock wrote.

A former senior HHS official told POLITICO that former HHS Secretary Alex Azar and his then-chief of staff, Brian Harrison, were behind the push to deregulate the medical devices without consulting the FDA — an action described as “not surprising since they consistently ignored the science throughout the pandemic.”

“This was perceived to be a deliberate attempt by Harrison to bolster his ‘small government' credentials ahead of his return to Texas,” the former senior official said. “Sadly, Azar is widely perceived as the anti-science Secretary because he enabled these types of bad decisions.”

WOODCOCK: DRUG REVIEW NOT CHANGING — FDA watchers shouldn’t read too much into the agency’s review of the performance of several drugs that received accelerated approval, Woodcock told the Alliance for a Stronger FDA on Wednesday.

When asked whether the reviews might indicate FDA is taking a “more stringent approach” than in the past to its oversight of drugs, the acting commissioner responded, “I don’t think so.”

The longtime drug regulator pointed to advancements in HIV drugs and cancer treatments as areas that have benefited from use of surrogate endpoints despite internal and external concerns.

“We would not have controlled [the HIV] epidemic the way we did and drug development would have been slowed tremendously,” Woodcock said. “But it was taking a big chance at the beginning, not later, but at the beginning. That kind of willingness or boldness is predicated on the idea that there is a need so great that you’re willing to take those kinds of chances.”

FDA PUBLISHES REMOTE FACILITY EVALUATION DETAILS — The FDA on Wednesday published guidance outlining how it will conduct remote, voluntary evaluations of drug, biologic and veterinary firms during the pandemic, and how the agency will use those findings.

The so-called “remote interactive evaluation” is not the same as an inspection, according to the FDA. But the agency says it will use the information it gleans from the remote evaluations to help meet timelines for product decisions governed by user fee agreements with industry.

Companies will not be able to ask for such evaluations. Instead, the agency will contact companies once it determines one “is appropriate for a particular facility or drug.” Declining such a request “could impede” a regulatory decision on the adequacy of clinical trials for a pending application or drug manufacturing operation.

“While they are attempting to use this to reduce the backlog, they are not going to use these interactive evaluations to eliminate the inspections entirely,” Cathy Burgess, an FDA lawyer who leads Alston & Bird’s compliance and enforcement team, told POLITICO. “They might use the information from the remote interactive evaluation to refine the scope and the timing for their inspection, but it doesn't obviate the need for an inspection.”

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HOUSE SENDS GENERIC DRUG BILLS TO BIDEN — The House on Wednesday sent the Advancing Education on Biosimilars Act and the Ensuring Innovation Act to President Joe Biden’s desk. The two bills aim to help bolster awareness of biosimilars and clarify what drugs qualify for market exclusivity.

THERMO FISHER REACHES $17.4B DEAL TO BUY PPD — Thermo Fisher Scientific announced Thursday it is acquiring clinical research organization PPD for $17.4 billion and the assumption of about $3.5 billion in debt. The deal is expected to close by the end of 2021.

U.S. TRADE CHIEF APPEALS TO VAX FIRMS — U.S. Trade Representative Katherine Tai on Wednesday told pharmaceutical companies that they must be prepared to make "sacrifices" to ensure that developing countries have access to Covid-19 vaccines. "The desperate needs that our people face in the current pandemic provides these companies with an opportunity to be the heroes they claim to be — and can be," Tai said in a speech during a closed-door World Trade Organization meeting, Doug Palmer reports.

RUSSIA’S DIVISIVE SPUTNIK SHOT — The European Medicines Agency has not yet approved Russia’s Sputnik V coronavirus vaccine, and the European Commission says the bloc won’t need it. But that hasn't stopped a number of governments — including Germany, Hungary and Slovakia — from breaking with the EU's common approach to cut their own deals, POLITICO EU’s Carlo Martuscelli and Laurenz Gehrke report. Russia's critics say it’s using the vaccine to sow division: Lithuanian Prime Minister Ingrida Šimonytė described Sputnik V in a tweet as a "hybrid weapon to divide and rule."

Viome adds Emmanuel Hanon as its global head of research and development. The pharma executive previously led R&D at GlaxoSmithKline’s vaccine unit.

A message from Pharmaceutical Care Management Association:

Medicare beneficiaries appreciate the Biden Administration’s decision to delay the prescription drug rebate rule which would increase Medicare Part D premiums 25% and cost taxpayers $170 billion. Congress and the Administration should now permanently repeal the rebate rule and instead advance real solutions that lower the costs of prescription drugs.

Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA.

A new drug review program in the works: The most recent batch of notes from a negotiating session between the FDA and industry to authorize the Prescription Drug User Fee Amendments (PDUFA) indicate that both sides are interested in the creation of a new accelerated review program for some drug products. The program, known as the Split Real-Time Application Review (STAR) program, would be modeled off the FDA’s Real-Time Oncology Review Pilot Program that helps to cut down some drug review timelines to just weeks. AgencyIQ has the full details here.

A different type of house inspection: The FDA this week issued a Warning Letter to a repackager of dietary supplements and drugs, warning the company for (among other issues) making products on an ottoman in a living room and washing production equipment in a residential dishwasher using dishwasher pods. As AgencyIQ found, the manufacturing “facility” is a house in a residential neighborhood.

Pfizer CEO Albert Bourla said in a pretaped interview aired Thursday on CNBC that it is likely people will need a third dose of coronavirus vaccine within a year.

CDRH Director Jeff Shuren and the FDA’s William Maisel detail the impact of the Covid-19 pandemic on the device center’s workload. The regulators write they “expect delays in meeting review timelines for certain non-COVID-19 submissions, even for files tied to Medical Device User Fee Amendments (MDUFA) commitments.”

FDA will hold a virtual public workshop on June 7-8 to discuss the science underlying morphine milligram equivalents.

FDA is asking for feedback on a Trump-era policy that identified seven Class I surgeon and patient examination gloves that HHS determined in January do not require premarket review.

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