Category: Daily News

MedPageToday reports that a group of clinicians and researchers has petitioned the FDA to delay fully approving any COVID-19 vaccines before clinical trials have been completed, calling the notion of approval to stimulate vaccination rates “backward logic.”

The group, led by Linda Wastila, BSPharm, MSPH, PhD, professor of pharmaceutical health services research at the University of Maryland School of Pharmacy, includes 27 petitioners, including 16 experts outside the U.S., primarily based in Europe.

“The message of our petition is ‘slow down and get the science right — there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.’ We believe the existing evidence base — both pre- and post-authorization — is simply not mature enough at this point,” they wrote in a blog post published in The BMJ.

“If the FDA listens to us, they won’t give serious consideration to approving a COVID-19 vaccine until 2022. Our first request is that the FDA require manufacturers to submit data from completed phase III trials — not interim results. Trials by vaccine manufacturers were designed to follow participants for two years, and should be completed before they are evaluated for full approval, even if they are now unblinded and lack placebo groups. These phase III trials are not simply efficacy studies; they also are necessary and important safety studies,” the group wrote.

Full approval is not necessary to address public health, they argued, because the emergency use authorizations that the FDA has already issued for three vaccines are substantial enough to provide adequate vaccine access.

However, full approval may convince more people to get vaccinated, the group tacitly acknowledged. “While approval might lead to increased public confidence in COVID-19 vaccines, as well as provide legal support for employer-instituted vaccine mandates, to approve a medical product for these reasons is outside FDA’s regulatory purview. Approval decisions must be driven by the safety and efficacy data,” they wrote in the blog post.

The group also asked the FDA to hold off approval until the agency:

– – Confirms there is substantial evidence that clinical effectiveness outweighs harms among special populations
– – Requires a “thorough” safety analysis of spike proteins produced in situ after vaccine administration, including studies on spike proteins’ “full biodistribution, pharmacokinetics, and tissue-specific toxicities”
– – Completes vaccine biodistribution studies “from administration site and safety implications of mRNA translation in distant tissues”
– – Comprehensively investigates all severe adverse reactions reported after vaccination
– – Examines the safety of people taking more than two doses
– – Includes gene delivery and therapy experts in its Vaccines and Related Biological Products Advisory Committee
– – Enforces “stringent conflict of interest requirements to ensure individuals involved in data analysis and decision making” related to Biologics License Applications lack such conflicts with the vaccine manufacturers

The group submitted their petition June 1, calling on FDA to provide an answer by June 11 in part “to allow Petitioners the opportunity to seek emergency judicial relief should the instant Petition be denied,” they stated. Group members also plan to lobby Congress, according to an email from the group to MedPage Today.

“Approving a COVID-19 vaccine now risks setting a precedent of lowered standards for future vaccine approvals. The ‘FDA approved’ seal must represent a high bar — and premature licensure of a COVID-19 vaccine could seriously damage public confidence in regulatory authorities, particularly if long-term safety issues were to emerge following licensure,” they wrote in the blog post.

The U.S. Department of Justice signaled its continued focus on enforcement of the federal Physician Payment Sunshine Act, when it announced the second major settlement involving Sunshine Act allegations in just over six months. Under the settlement, which also resolves claims asserted in a qui tam lawsuit,

Medicrea International, a French medical device manufacturer, and its American affiliate, Medicrea USA Inc.agreed to pay $1 million to resolve allegations that it failed to fully report certain payments and transfers of value under the Sunshine Act as well as $1 million to resolve alleged violations of the federal Anti-Kickback Statute and federal False Claims Act.

The California Attorney General also announced that California will receive nearly $93,000 from this settlement.

The settlement agreement arise from allegations that during an ex-U.S. medical professional society meeting in 2013 in Lyon, France, Medicrea provided meals, alcoholic beverages, entertainment, and coverage of travel expenses to U.S.-based physicians to induce these physicians to purchase or order Medicrea’s spinal devices, resulting in the submission of false claims to the government, and failed to fully report such payments and transfers of value to the Centers for Medicare & Medicaid Services as required under the Sunshine Act.

The Sunshine Act requires manufacturers of certain products that are reimbursed by Medicare, Medicaid, or the Children’s Health Insurance Program to track and annually report all payments and other transfers of value made to certain healthcare providers and U.S. teaching hospitals, collectively referred to as “covered recipients,” unless an exception applies. See 42 U.S.C. § 1320a-7h; see also 42 C.F.R. § 403.904.

In 2020, the U.S. DOJ announced a settlement with medical device manufacturer Medtronic USA Inc.for $9.2 million to resolve allegations that: the company paid kickbacks to induce a neurosurgeon to use its products; and failed to accurately report payments to this neurosurgeon in violation of the Physician Payments Sunshine Act.

This settlement arises from an investigation into certain financial arrangements between Medtronic and South Dakota-based neurosurgeon Wilson Asfora. The government alleged that Medtronic, at Dr. Asfora’s request and contrary to the company’s compliance policies, agreed to pay for events at Carnaval Brazilian Grill, a local restaurant owned by Dr. Asfora and his wife. Allegations in the settlement agreement claim that  Medtronic held over 130 events at Carnaval for which it paid over $87,000 to Dr. Asfora’s restaurant.

Medtronic’s sales personnel allegedly stated in internal expense reports that the events were held to discuss educational content or business information. However, the government alleged that these events were social events that included the provision of lavish meals and alcohol to social acquaintances, business partners, favored colleagues, and referral sources selected by Dr. Asfora, with little or no discussion of Medtronic products.

Immediately after the 2020 settlement, Medtronic announced that it has completed its friendly tender offer for Medicrea International. As a result of completion of the tender offer, Medtronic currently owns in excess of 90% of Medicrea’s share capital and voting rights and was expected to request the implementation of a squeeze-out procedure under French law, which will result in Medicrea becoming a wholly-owned subsidiary of Medtronic.

Less than a year later, its acquisition target was accused of a similar Sunshine Act violation.

Until these recent settlements, there had been no public enforcement actions involving Sunshine Act violations. However, following Congress’s expansion of the Sunshine Act in October 2018 to include five new categories of “covered recipients” subject to reporting requirements, the Senate Finance Committee requested that CMS review the Open Payments database for potential Sunshine Act violations.

In a case that could make the federal government reconsider how it classifies marijuana, a lawyer urged a Ninth Circuit panel Thursday to make the U.S. Drug Enforcement Administration reassess its 49-year-old position that cannabis has no accepted medical use.  The Ninth Circuit includes California, thus this is a case of significance for the issue in workers’ compensation claims for our state.

“It’s a relic of a bygone era,” attorney Shane Pennington told a three-judge Ninth Circuit panel.

According to the report in Courthouse News, Pennington represents Dr. Suzanne Sisley, an Arizona-based medical marijuana researcher, and three veterans who claim they suffer ongoing harm from the federal government’s refusal to reclassify cannabis as a drug with medicinal benefits. Their Ninth Circuit petition highlights research Sisley has conducted using marijuana to treat veterans who suffer from post-traumatic stress disorder.

Despite the fact that medical marijuana is legal in 36 states, the DEA has classified cannabis as a Schedule I drug – the most restrictive category – since 1972. Congress empowered the DEA to decide how drugs should be classified in the Controlled Substances Act of 1970. That was around the same time former President Richard Nixon declared a “war on drugs.”

The petitioners argue a five-factor test the DEA established in 1992 to determine if a drug has any medical benefit is arbitrary, leads to absurd results and contradicts the will of Congress.

But most of the Ninth Circuit hearing focused not on the wisdom of the DEA’s decision or its criteria for categorizing drugs. Rather, it focused on whether the petitioners have standing to bring their challenge in federal court.

That’s because Sisley and the veterans are challenging the denial of a petition they never filed. The one-page, handwritten petition asking the DEA to reclassify marijuana was filed by Stephen Zyszkiewicz and Jeramy Bowers in January 2020. The DEA denied the petition four months later. Zyszkiewicz and Bowers have two separate lawsuits pending over the denial in the District of Columbia.

“This is a really odd case,” Circuit Judge Willaim Fletcher, a Bill Clinton appointee, told lawyers challenging the DEA’s decision. “You appealed the denial of somebody else’s petition. I’ve never seen a case like this.”

But it’s not unprecedented, according to Matthew Zorn, another lawyer representing Sisley and the veterans.

To support his position, Zorn cited the seminal 2007 Supreme Court case, Massachusetts v. EPA, which forced the federal agency to start regulating greenhouse gas emissions to combat climate change. In that case, Massachusetts was challenging the denial of a petition filed by someone else.

“None of the judges at the D.C. Circuit or on the Supreme Court thought anything about it, that Massachusetts was filing a petition for review on another party’s petition,” Zorn said.

Drawing a distinction, Justice Department lawyer Daniel Aguilar told the panel that Massachusetts had standing in that case only because the Supreme Court found it deserved “special solicitude” as a “sovereign state.”

Responding to a question posed by Circuit Judge Daniel Collins, a Donald Trump appointee, Aguilar acknowledged the Massachusetts v. EPA court never squarely addressed the question of whether a party can challenge the denial of a petition it did not file. But he insisted that no case law exists to support that notion.

Fletcher indicated that he agrees with that position.

U.S. Circuit Judge Paul Watford, a Barack Obama appointee, suggested that allowing people to challenge decisions on petitions they didn’t file could lead to a flood of litigation. Potentially tens of millions of people allegedly harmed by the DEA’s decision could file their own challenges to the petition denial in separate circuit courts across the country, Watford said.

After 33 minutes of debate, the panel took the arguments under submission.

The Summer 2021 edition of Healthesystems.com RxInformer covers diverse topics such as the future of telemedicine and practical tips to make it effective in workers’ compensation.

Telemedicine use has increased in response to the COVID-19 pandemic and is gaining acceptance in workers’ comp. While some obstacles remain, telemedicine has the potential to expand care delivery options and speed recovery times.

According to a recent study by McKinsey, consumer interest in telemedicine rose from 11% to 76% during the pandemic, 57% of healthcare providers said they viewed telemedicine more favorably, and 64% of providers are comfortable using telemedicine. In the course of just a few months, telemedicine physician visits rose 50 – 175x, depending on geography and type of practice.

In workers’ comp, telemedicine also gained wider acceptance during the pandemic as many states relaxed restrictions regarding its use for injured worker patients. The types of changes made by the states (and CMS, which guides rules for some states) vary and include: allowing additional services to be delivered via tele technologies; relaxing provider licensing requirements; amending reimbursement rules (often reimbursing at the higher office visit rates to encourage telemedicine use); and allowing different modes of technology, such as audio-only calls.

Many of the legal and regulatory changes regarding telemedicine are temporary, and it remains to be seen which will become permanent and where. Workers’ comp stakeholders had hopes of cost reduction through telemedicine, both indirectly by speeding recovery times with better access to care, and directly through lower provider fees for virtual visits. To encourage the use of telemedicine during the pandemic, many states have allowed in-office reimbursement rates for virtual visits, which eliminates the direct savings incentive and makes the reimbursement question an important one going forward.

Exactly which medical services can be effectively delivered through telemedicine is also yet to be determined. Currently, fewer than 100 medical services are approved for telemedicine by CMS, which is a small fraction of the 8,000+ services covered by Medicare and Medicaid. The number of medical services we commonly see in workers’ comp are much fewer and, while some services will always require that the provider and patient be physically together, a significant portion of injured worker care could potentially be delivered virtually.

Telemedicine is not appropriate for all medical services. Serious injuries and illness demand in-person attention, and most diagnostic tests and all surgeries require physical contact with the patient. In addition to these obvious exceptions, some patients may feel that they are not getting proper care with a telemedicine visit and prefer to see their healthcare provider in person. There are also important privacy concerns and fear of fraud in both general healthcare and workers’ comp.

Merck announced it has entered into a procurement agreement with the United States government for molnupiravir (MK-4482). Molnupiravir is currently being evaluated in a Phase 3 clinical trial, the MOVe-OUT study, for the treatment of non-hospitalized patients with laboratory-confirmed COVID-19 and at least one risk factor associated with poor disease outcomes. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics.

“Merck is pleased to collaborate with the U.S. government on this new agreement that will provide Americans with COVID-19 access to molnupiravir – an investigational oral therapy being studied for outpatient use early in the course of disease – if it is authorized or approved,’ said Rob Davis, president, Merck. ‘In addition to this agreement with the U.S. government, we are actively engaged in numerous efforts to make molnupiravir available globally to fulfill Merck’s commitment to widespread access.’

Through the agreement, if molnupiravir receives Emergency Use Authorization (EUA) or approval by the U.S. Food and Drug Administration (FDA), Merck will receive approximately $1.2 billion to supply approximately 1.7 million courses of molnupiravir to the United States government. Merck has been investing at risk to support development and scale-up production of molnupiravir and expects to have more than 10 million courses of therapy available by the end of 2021.

Merck also plans to submit applications for emergency use or approval to regulatory bodies outside of the U.S. and is currently in discussions with other countries interested in advance purchase agreements for molnupiravir. Merck is committed to providing timely access to molnupiravir globally and intends to implement a tiered pricing approach based on World Bank data that recognizes countries’ relative ability to finance their public health response to the pandemic.

As part of its access strategy, Merck has also entered into non-exclusive voluntary licensing agreements for molnupiravir with established generic manufacturers to accelerate availability of molnupiravir in 104 low- and middle-income countries following approvals or emergency authorization by local regulatory agencies.

In addition to developing molnupiravir, Merck is contributing to the pandemic response by collaborating with Johnson & Johnson to support the manufacture of its COVID-19 vaccine.

This procurement of molnupiravir will be supported in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, in collaboration with the DOD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense.