The U.S. Food and Drug Administration (FDA) updated the Paxlovid Emergency Use Authorization (EUA), allowing Paxlovid that is currently in U.S. distribution to remain authorized for use through the labeled or extended expiration date, or until March 8, 2024, whichever comes first. EUA-labeled Paxlovid will no longer be authorized for emergency use after March 8.
The Paxlovid EUA will continue to authorize emergency use of Paxlovid manufactured and labeled in accordance with New Drug Application (NDA-labeled Paxlovid) for treating mild-to-moderate COVID-19 in high-risk pediatric patients (12 years of age and older) who are at high risk for progression to severe COVID-19.
Pharmacies may continue to dispense unexpired EUA-labeled Paxlovid through March 8. Any expired EUA-labeled Paxlovid and/or unused EUA-labeled Paxlovid remaining after March 8, must be returned to the manufacturer, or disposed of in accordance with federal, state and local regulations.
Patients with Paxlovid prescriptions will receive either EUA-labeled or NDA-labeled Paxlovid until March 8. After that, patients will receive NDA-labeled Paxlovid. More information about the difference in packaging between EUA-labeled and NDA-labeled Paxlovid is available on the FDA website.
Eligible patients can receive free Paxlovid through the PAXCESS Program until Dec. 31, 2024.
“In the midst of every crisis, lies great opportunity.” — Albert Einstein
The shortage of key cancer treatment drugs carboplatin and cisplatin made national headlines in recent weeks, as hospitals implemented multiple strategies to maintain care for their patients when supply of these two drugs was remarkably low to nonexistent. While this shortage deservedly caught the attention of the nation, hospitals must navigate dozens to hundreds of drug shortages every day. This shortage is a worst-case example of how inefficiencies in the pharmaceutical supply chain can have devasting impacts on patient care.
Unfortunately, hospitals far too often must manage short supply of drugs, seek alternative sources for drugs, adjust treatment regimens and collaborate with other health systems to maximize supply. Hospitals throughout the state used all these tactics to respond to the recent crisis.
I’m proud the MHA was able to quickly raise the flag on this issue to our lawmakers as soon as we became aware of it. U.S. Senator Gary Peters (D-Bloomfield Twp.) chairs the Senate Committee on Homeland Security & Governmental Affairs and has prioritized drug shortages as a national security concern. His report from March 2023 shares a wealth of information on the subject, including all the problems associated with drug shortages and recommended solutions. His committee has been a key partner in providing accurate information about the shortage to Michigan hospitals.
In addition, U.S. Representatives Debbie Dingell (D-Ann Arbor) and Tim Walberg (R-Tipton) led Michigan’s US House delegation in sending a bipartisan letter May 24 to Food and Drug Administration (FDA) Commissioner Dr. Robert Califf to take immediate action to mitigate the effects of the nationwide shortage. I’m happy to share every member of our House delegation signed on to the letter, showing the health of our hospitals, patients and communities is truly a bipartisan issue.
Our work will continue on this issue far after the supply of these two drugs stabilizes, as the MHA supports several strategies that will address drug shortages. The first is relaxing prior authorization requirements from health insurers for alternative therapies during a shortage so they can be used widely. Federally, we believe establishing an early warning system will help avoid or minimize drug shortages so both manufacturers and providers have more time to respond to an upcoming shortage. Healthcare providers also welcome improved communication from the FDA and drug manufacturers, as there is often little to no transparency on the cause of a drug shortage. Lastly, changing the economic model to encourage drug manufacturers to stay in, re-enter or initially enter the market would be beneficial to all stakeholders. Many shortages occur with generic drugs due to a limited number of drug manufacturers.
In addition to the public policy arena, it is noteworthy that hospitals across the country – including several of our MHA members – helped to launch Civica, an entity that is helping to increase the production and availability of key generic drugs. While not directly applicable to the current cancer drug shortage at this time, this effort is an example of the field looking to the future and doing all we can to ensure appropriate healthcare access to patients.
Finally, I’d like to lift up the MHA’s response to this crisis as a great example of the value of an association. Since we represent all acute care community hospitals in Michigan, we’re able to speak with a unified voice. The MHA has the relationships and institutional knowledge to quickly convene ad hoc groups in times of crisis to gather knowledge on the subject and what needs to be done, and then can execute and utilize our long-standing partnerships with lawmakers, both at the state and federal levels, to generate necessary awareness and action. By looking at national headlines, Michigan has been a leader in the shortage of carboplatin and cisplatin. That’s a testament to the health of our association and the culture we have helped to establish, whereby safety and quality engender collaboration and not competition within our hospital and health system membership.
The MHA has been in frequent contact with members of the Michigan Congressional delegation since the association was made aware of shortages of the chemotherapy drugs carboplatin and cisplatin. Representatives Debbie Dingell (D-Ann Arbor) and Tim Walberg (R-Tipton) led the Michigan delegation in sending a bipartisan letter May 24 to Food and Drug Administration (FDA) Commissioner Dr. Robert Califf to urge the FDA to take immediate action to mitigate the effects of the nationwide shortage of chemotherapy medications. Every member of the Michigan delegation signed on to the letter.
U.S. Senators Gary Peters (D-Bloomfield Twp.) and Debbie Stabenow (D-Lansing), along with U.S. Representative Elissa Slotkin (D-Lansing), wrote a separate letter to Dr. Califf asking that the FDA do everything in its power to mitigate the dire shortage of cancer drugs that has reached crisis levels in recent months.
The office of Sen. Peters also provided the following information to the MHA during the week of May 22 regarding the shortages.
The shortages for each drug are caused by the manufacturer Accord deciding to place production on hold, pending further assessments. Four other manufacturers of the drugs have not been able to fill the supply gap left by Accord.
The FDA has continued to work with Accord on prioritization of their assessments for product release and cisplatin and carboplatin are prioritized for release. Cisplatin is now being released following the assessment and supplies are making their way to hospitals and cancer centers. Meanwhile, carboplatin is planned to be released soon.
The FDA is also working with the other four manufacturers to increase supply and are offering expedited review of anything needed to increase supply, such as additional manufacturing lines, facilities and suppliers.
The FDA is requesting the manufacturers provide data to extend expiration dating for lots on the market that remain in distribution but are nearing expiration. Once received, the FDA will post the drug, old lot number and new lot number on the Extended Use database on the Drug Shortage website.
In addition, the FDA is exploring temporary importation to meet patient needs during the shortage. During temporary import, the FDA evaluates the overseas product attributes, as well as the manufacturing facilities, to ensure no risks exist for US patients.
Updates for both cisplatin and carboplatin are being provided by the FDA on the drug’s FDA Drug Shortage webpages.
Members with questions may contact Renee Smiddy with the MHA.
Manufacturing delays at several pharmaceutical companies are causing nationwide shortages of two critical chemotherapy medications – forcing Michigan hospitals and health systems to find alternative treatments for patients, some of which may be less effective. The two drugs are cisplatin and carboplatin and are used to treat several types of cancer, including bladder, lung, ovarian and testicular cancers. The shortage of these chemotherapy drugs is widespread across the country, impacting hospitals throughout all regions of Michigan.
Both drugs are provided by healthcare providers as injections to oncology patients. The shortage of cisplatin was originally reported to the U.S. Food & Drug Administration (FDA) Feb. 10, 2023, while carboplatin was reported April 28, 2023. Both shortage durations are expected to last at least into June 2023.
To reduce the impact of shortages on patients, hospitals are trying many different solutions, including managing existing supply, seeking alternative sources for drugs in short supply, adjusting chemotherapy regimens for impacted patients and working with healthcare systems, as well as state and federal officials, to mitigate these challenges.
“The priority of hospitals is delivering the right care to every patient, every time,” said MHA CEO Brian Peters. “Drug shortages severely hamper a hospital’s ability to provide patients with the best treatment, while forcing hospitals to implement strategies that may increase the cost of care and sometimes do not offer the same effectiveness in treatment.”
This current shortage follows a national trend of drug shortages impacting healthcare providers for years. A survey of medical oncologists published in the New England Journal of Medicine found 83% were unable to prescribe their preferred chemotherapy agent due to shortages.
The MHA supports the following strategies that will address the issue:
Relaxing prior authorization requirements from health insurers for alternative therapies so they can be widely used, as appropriate.
Establishing an early warning system to help avoid or minimize drug shortages.
Removing regulatory obstacles faced by manufacturers and the FDA as a way of averting or mitigating drug shortages and allowing drug imports.
Improving communication with healthcare providers, including extent and timeliness of information. There often is no transparency on the cause of a drug shortage and many shortages occur with generic drugs.
Exploring incentives to encourage drug manufacturers to stay in, re-enter or initially enter the market.
Patients concerned about the impact of this drug shortage should contact their healthcare provider.
The Michigan Legislature returned to session the week of April 10, taking up several bills the MHA is monitoring. In the House of Representatives, MHA-supported legislation to create a new tax credit for blood donations and to regulate the sale of kratom received hearings in their respective committees. In the Senate, a package of bills to license and regulate professional guardians was introduced and testimony was held on a bill to allow for pharmacists to order and administer certain vaccinations and diagnostic tests.
The House Committee on Tax Policy held a hearing on House Bill (HB) 4068 to create a new tax credit for blood donations in Michigan. Introduced by Rep. Rachel Hood (D-Grand Rapids), the bill would allow for a $25 state income tax credit for each blood donation during the tax year. The MHA is supportive of the bill, which is a unique way of encouraging good public health decisions in the state. A vote was not held at this hearing.
In the House Regulatory Reform Committee, an initial hearing was held on legislation to regulate the sale of kratom in Michigan. Kratom is a tropical tree native to Southeast Asia, with leaves that contain compounds which can have psychotropic effects similar to opioids and stimulants. HB 4061 would ban adulterated kratom products, require warning labels addressing the potential health impacts and require lab testing for kratom products to ensure consumers know what substances are present. HB 4061 is a reintroduction by Rep. Lori Stone (D-Warren) and was supported by the MHA’s Legislative Policy Panel last session. No vote on the bill was taken.
In the Senate’s Health Policy Committee, Sen. Sylvia Santana presented a new bill intended to increase access to vaccines and certain laboratory tests. Senate Bill (SB) 219 would allow pharmacists to order and administer vaccinations and certain diagnostic tests for their patients without physician supervision. Under the bill, the diagnostic tests pharmacists would be allowed to perform would be limited to those that are waived for home use by the Food and Drug Administration or approved for waiver under the Clinical Laboratory Improvement Amendments of 1988. The MHA has not yet taken a position on SB 219, which has also been introduced in the House as HB 4316 by Rep. Alabas Farhat (D-Dearborn). The MHA expects further testimony to be taken on the bill and no votes were held at this time.
In the Senate, a new package of six bills to amend regulations for professional guardians was introduced. SBs 253–258 include a wide range of proposals to increase the requirements for professional guardians, limit the number of cases a guardian can take and change the priority list for court-appointed guardians. The MHA has concerns with the legislation impacting a hospital’s ability to secure court appointed guardians in a timely manner to engage with healthcare and placement decisions. No hearing is scheduled on the bills at this time.
Members with questions about state legislative action can reach out to Adam Carlson for more information.
Michigan’s COVID-19 case numbers and hospitalizations have increased since early July with the onset of omicron variant BA.5. Here are the latest key statistics:
875 hospitalizations with confirmed or suspected COVID-19, a 20% increase since July 1.
23 pediatric hospitalizations with confirmed or suspected COVID-19.
67.6% of all residents have at least one dose of vaccine.
29.2% of kids aged 5-11 have now initiated vaccination.
Roughly 2% of kids aged 6 months-5 years have initiated vaccination since approval was granted in mid-June.
The MHA continues to keep members apprised of pandemic-related developments affecting hospitals through email updates and the MHA Coronavirus webpage. Important updates are outlined below.
Governor Signs COVID-19 Liability Legislation
Gov. Gretchen Whitmer recently signed several COVID-19 liability-related bills:
House Bill 5244 (Public Act 138 of 2022) amends Public Act 238 of 2020, which prohibits an employer from taking certain actions against an employee who does not report to work under circumstances related to COVID-19, to specify that the Act would not apply to a claim or cause of action that accrued after July 1, 2022. In addition, the bill will repeal PA 238 of 2020 effective July 1, 2023. HB 5244 was sponsored by Rep. Andrew Fink (R-Hillsdale).
House Bill 6128 (Public Act 140 of 2022) amends Section 85 of the Michigan Occupational Safety and Health Act to specify that certain conditions establishing immunity for employers whose employees were exposed to COVID-19 would not apply to an exposure that occurred after July 1, 2022. In addition, the bill would repeal Section 85 and Section 85a, which defines COVID-19 under the Act, effective July 1, 2023. HB 6128 was sponsored by Rep. Yousef Rabhi (D-Ann Arbor).
House Bill 6215 (Public Act 139 of 2022) amends the COVID-19 Response and Reopening Liability Assurance Act to specify that the Act, which provides immunity to a person that acts in compliance with certain federal, state and local orders related to COVID-19, would not apply to a claim or cause of action that accrued after July 1, 2022. In addition, the bill would repeal the Act effective July 1, 2023. House Bill 6215 was sponsored by Rep. Graham Filler (R-DeWitt).
Novavax Vaccine Gets FDA Authorization
The Food and Drug Administration (FDA) granted emergency use authorization to Novavax’s COVID-19 vaccine July 13. The vaccine is a two-dose series administered three weeks apart and uses a different, older vaccine technology than is used in the messenger RNA vaccines and Johnson & Johnson shot.
Novavax’s vaccine is authorized for people ages 18 and older as a primary series. It may be appealing to those adults who were hesitant to receive another brand of vaccine due to the components or development process.
In a trial of more than 26,000 adults, two doses of the Novavax COVID-19 vaccine were more than 90 percent effective at preventing symptomatic disease. For adults 65 and older, effectiveness was more than 78 percent. There were no serious side effects or safety concerns.
The Centers for Disease Control and Prevention (CDC) will next decide whether it will endorse the vaccine. The CDC Advisory Committee on Immunization Practices will meet July 19, though an agenda is not yet available.
The Biden administration recently announced that it had purchased 3.2 million doses of the Novavax vaccine. If the vaccine is recommended by the CDC, it will be made available at no cost to states, jurisdictions, federal pharmacy partners and federally qualified health centers. The MHA will keep members apprised of vaccine availability and ordering processes at the appropriate time. Members with questions may contact Ruthanne Sudderth at the MHA.