FDA Commissioner Scott Gottlieb resigns, Eli Lilly will offer a discount version of its insulin, and a second HIV patient is cured. Welcome to This Week in Managed Care, I’m Laura Joszt.
Dr Scott Gottlieb Steps Down as FDA Commissioner
Scott Gottlieb, MD, who joined the FDA as commissioner in May 2017, will leave his post in 1 month.
After The Washington Post first reported his decision, Gottlieb shared the news with colleagues on his FDA Twitter account, posting: “There’s perhaps nothing that could pull me away from this role other than the challenge of being apart from my family for these past 2 years and missing my wife and 3 young children. I’ll depart knowing that the FDA is strong, its people outstanding, and its mission well recognized and deeply respected across the government, and indeed, across the world. I consider myself truly fortunate to have had the chance to help lead this remarkable institution.”
In January, Gottlieb had dismissed rumors he was leaving FDA after commuting to Washington from his Connecticut home for nearly 2 years. He had overcome skepticism about his ties to the pharmaceutical industry and won praise for several initiatives, including:
- Fighting the opioid crisis
- Combatting teen use of e-cigarettes
- Restructuring the drug approval process and promoting generics
- Laying the groundwork for broader use of real-word evidence
HHS Secretary Alex Azar praised Gottlieb’s work, saying: “Scott’s leadership inspired historic results from the FDA team, which delivered record approvals of both innovative treatments and affordable generic drugs, while advancing important policies to confront opioid addiction, tobacco, and youth e-cigarette use, chronic disease, and more. The public health of our country is better off for the work Scott and the entire FDA team have done over the last 2 years.”
For more reaction to Gottlieb’s departure, visit ajmc.com.
Eli Lilly to Sell Generic Version of Humalog
Eli Lilly, under fire from the Trump administration, Congress, and consumers for soaring insulin prices, announced this week it will introduce a half-price version of Humalog, its popular fast-acting insulin.
The authorized generic will be the same product produced in the same plant, but sold under the molecular name, insulin lispro. In a statement, the Indianapolis-based manufacturer noted:
- The price of the new generic will be $137.35 per vial, or 50% of the cost of the branded version.
- A 5-pack of Kwik pens will be $265.20
- Both will be produced through a Lilly subsidiary, ImClone Systems, and Lilly will work across the supply chain to get the generic to consumers as quickly as possible.
But David Ricks, chief executive officer, Eli Lilly, still pointed fingers at the rebate system in his statement, saying: “We’ve engaged in discussions about the price of insulin with many different stakeholders in America’s healthcare system: people living with diabetes, caregivers, advocacy groups, healthcare professionals, payers, wholesalers, lawmakers, and leading healthcare scholars. Solutions that lower the cost of insulin at the pharmacy have been introduced in recent months, but more people need help.”
Researchers Cure Second person of HIV
Researchers in London say a second patient has been cured of infection with HIV, more than 10 years after the first. The case, reported this week in the journal Nature, also involved the use of a bone marrow transplant. Experts say while this is an important milestone in the fight against HIV, the difficulty and expense of this method makes it unlikely that it will be widely used. Many similar attempts have failed, but there are drugs available that can control the infection.
To read more about HIV, visit our HIV compendium page at ajmc.com.
Study Dispels Myths Surrounding Measles, Mumps, and Rubella (MMR) Vaccine
With 206 cases of measles reported so far in 2019, a new study has found no connection between the MMR and autism. The study, reported in the Annals of Internal Medicine, featured an analysis of subgroups of children that opponents of vaccines claim might be more vulnerable to perceived effects of the MMR.
Researchers drew from more than 650,000 cases from a health registry in Denmark, where the vaccination program is free and voluntary. No increase in autism was found in the overall population or in the perceived at-risk subgroup.
The World Health Organization recently called vaccine hesitancy one of the top 10 threats to global health in 2019. For more, visit ajmc.com.
Opioid Use Disorder Guidelines for Buprenorphine Prescribing
Finally, the current issue of The American Journal of Managed Care® features guidelines to help physicians who want to use buprenorphine to treat opioid addiction. The guidelines, authored by researchers from axialHealthcare are based on a literature review from 2009 to 2018.
The authors conclude: “Linking pharmacy and medical billing claims data to evidence-supported best practices provides public and private payers the ability to track individual patients, facilitate high-quality care, and monitor outcomes. For the full article, visit ajmc.com.
Via American Journal of Managed Care.