An adult hold the hand of a child with an IV

Teva to Resume Production of Critical Pediatric Oncology Drug: Too Little, Too Late

By Beatrice Brown

In my last blog post, I reflected on the ethical issues relevant to a critical shortage of a widely used pediatric oncology drug, vincristine. The shortage occurred after one of two pharmaceutical companies producing the drug, Teva, withdrew from the market, and the other, Pfizer, was unable to keep up with the demand due to manufacturing delays. On November 13, Teva announced that they would resume production of vincristine. The announcement stressed that they have decided to re-introduce the product because of the anticipated lack of “reliable single supply in the near term.” They also seemed to shift the moral blame from their decision, stating that “When Teva removed vincristine from the market earlier in the year there was no indication at all of a possible shortage” and that they assumed that Pfizer, which supplied 97% of the market, could easily absorb the demand. Furthermore, Teva emphasized that before discontinuing a product, they “always evaluate the need” for it, noting the caveat that they usually do not know supply challenges that other manufactures may be facing. However, as noted by Forbes, there will be no “short-term impact on the ongoing shortage” as a result of Teva’s decision, as their new supply of vincristine will not be available until early in 2020.

I raised the question in my last blog post on the shortage of vincristine of whether pharmaceutical companies have a moral obligation to continue producing a critical drug, even if the decision is announced in advance. I argued that it would have been more ethically permissible for Teva to have reduced production over time, eventually halting production, in order to alleviate the issue of manufacturing delays that Pfizer subsequently faced. I would like to further explore this question in light of Teva’s recent decision to resume production. Read More

A sick child lies in a hospital bed. An IV pole is visible in the foreground

Ethical Reflections on the Recent Critical Shortage of Pediatric Cancer Drug

By Beatrice Brown

Recently, news broke that there is a critical shortage of vincristine, a drug that is integral for treating pediatric cancers. According to the Children’s Oncology Group, Pfizer communicated that they were experiencing a shortage of the drug due to a manufacturing delay. Pfizer is now the sole supplier of vincristine in the United States after the other supplier, Teva Pharmaceuticals, ceased production of the drug after making a “business decision.” Although the FDA announced that deliveries of the drug should resume in late October, it is predicted that there will still be a supply shortage until December or January.

Vincristine is “the single most widely used chemotherapeutic in childhood cancer,” according to Yoram Unguru, MD, a pediatric hematologist and oncologist at the Herman and Walter Samuelson Children’s Hospital at Sinai and Johns Hopkins Berman Institute of Bioethics in Baltimore, Maryland. Unguru stated, “Nearly every child with cancer in the U.S. will receive multiple doses of vincristine over the course of their treatment. For some children with cancer, vincristine comprises one half of all chemotherapy administered.”

The shortage is even more critical given that there is no other manufacturer that can pick up the slack. According to Unguru, the shortage was predictable once Teva halted production. Given that there is no substitute for vincristine, doctors are in a tough position. Thus, there are two ethical issues I wish to explore here: 1) the issue of resource allocation/drug rationing; and 2) the moral obligations of pharmaceutical companies to patients. I will take up each of these issues in turn. Read More

Photograph of a person holding an e-cigarette in one hand and traditional cigarettes in the other hand.

FDA’s Warning Letter to Juul & the First Amendment

By Daniel Aaron

On September 10, 2019, the Food and Drug Administration (FDA) issued a warning letter to Juul asserting that the vaping manufacturer had violated federal law by illegally marketing its e-cigarettes as safer than other products. Citing evidence uncovered at a July 2019 House Subcommittee hearing as well as industry documents, FDA claims that Juul marketed its products as modified-risk tobacco products (MRTPs) without an FDA order allowing the product to be marketed as such. Therefore, FDA concluded, Juul’s products are adulterated.

At first blush, this seems like a heavy-hitting letter. FDA warning letters are an effective enforcement tool because they intimidate regulated entities and carry the threat of further enforcement. FDA likely hopes Juul will bring itself into compliance with federal law by ceasing to market its products as lower-risk.

However, enforcement letters carry no legal weight in and of themselves. Should Juul continue to market its products as lower-risk, there may be a long legal battle implicating the First Amendment.

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Technical illustration of a respirator device

Why Medical Device Regulation?

By Carmel Shachar

The Petrie-Flom Center’s 2020 annual conference, Innovation and Protection: The Future of Medical Device Regulation, co-sponsored by the University of Copenhagen’s Center for Advanced Studies in Biomedical Innovation Law and the University of Arizona Health Law Program, was inspired by a growing sense that there is a need to reconsider our regulatory approach to medical devices as they become increasingly complex. Not only are medical devices becoming more mechanically complex, but they are also increasingly merging with digital technologies to expand capabilities.

Devices’ increasing complexity raises questions as to whether our regulatory pathways for medical devices are appropriate for ensuring safety and efficacy. The New York Times in a May 4, 2019 Editorial Opinion indicated that they believed the answer is no—that our current regulatory system, especially the 510(k) pathway and limited post-market surveillance, risk patient lives and health. The European Council is implementing new medical device regulations in May 2020 and 2022 to address similar concerns around safety and effectiveness in the EU. Both American and European regulators are struggling to find the best way to oversee the new hybrid medical devices that incorporate both hardware and software, as well as stand-alone algorithms.

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Black silhouette of a woman looking down

The FDA’s NEST Initiative and Women’s Health

The history of medical device regulation in the United States has been shaped by the prominent failure of individual devices, many of which were indicated for women.

The Dalkon Shield intrauterine device infamously ushered in the 1976 amendments to the Federal Food, Drug, and Cosmetics Act, establishing the first pre-market notification and approval process for medical devices in the United States. Similarly, a series of failures among devices designed for women’s health—including the power morcellator, the Essure System, and pelvic mesh—has recently invigorated the FDA’s focus on its post-market regime. Read More

Pills spilling out of a few bills rolled in a cylinder

The Funding Effect: How Drug Manufacturers Design Clinical Trials to Produce Favorable Results

By Ryan J. Duplechin

Many consumers are unaware that the U.S. Food and Drug Administration (“FDA”) does not test drugs in the approval process. Instead, drug manufacturers test their drugs and submit their own results to the FDA for review. Hoping to convince the FDA and investors of the safety and effectiveness of their new drug, manufacturers go to great lengths to report positive results in clinical trials. Read More

Illustration of mitochondrial donation

Time to Revisit the Prohibition on So-Called “Three-Parent IVF”?

In an editorial appropriately titled, “This Editorial Is Not About Designer Babies,” the New York Times supported efforts by the Petrie-Flom Center and suggested it was time for Congress to consider lifting the effective ban on mitochondrial replacement therapies — sometimes colloquially but inaccurately referred to as “three-parent IVF.”

The piece referred to the Petrie-Flom Center’s upcoming public event and Roundtable, where experts will have a general conversation about the state of the law in the U.S. and elsewhere and to, as a group, discuss whether the prohibition against MRT might be lifted and, if so, how that might be accomplished.

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New HarvardX Course on the FDA and Prescription Drugs

Interested in learning more about pharmaceutical policy? Curious about the role of the FDA in ensure safe and effective drugs reach the market? Wondering why drug prices are so high in the US? Readers of my prior posts may enjoy learning more about these topics!

Check out a free HarvardX online course, “The FDA and Prescription Drugs: Current Controversies in Context,” put together by Petrie-Flom Center affiliates Dr. Aaron Kesselheim, Dr. Ameet Sarpatwari, Dr. Jonathan Darrow, and many others, that is now open for enrollment. (Disclosure: I did not play any role in the development or making of the course, but I am serving as a teaching assistant/discussion moderator for the course). Read More

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Aaron Kesselheim and Jonathan Darrow on “The Week in Health Law” Podcast

I am joined by Aaron Kesselheim and Jonathan Darrow, faculty members at Harvard Medical School and members of the Program On Regulation, Therapeutics, And Law (PORTAL) group directed by Dr. Kesselheim.

The conversation began with a discussion about drug price narratives, including whether drug prices are still increasing? We also critically discussed at least some of Vox’s 8 ideas for bringing down drug prices, and some better ones! The conversation then shifted to some issues, including pricing and expectations, with gene therapy drugs. We spent a short time on the resignation of Food and Drug Administration Commissioner Scott Gottlieb before ending our discussion with some information about PORTAL’s innovative online course, “The FDA and Prescription Drugs: Current Controversies in Context.”

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FDA scott gottlieb

FDA Commissioner Gottlieb Resigns: Twitter Reactions

Citing wanting to spend more time with his family, Food and Drug Administration commissioner Scott Gottlieb announced his resignation this week. Broadly liked on both sides of the aisle and within the biopharma industry, Gottlieb, a former physician and cancer survivor, made teen tobacco use a major issue during his two-year tenure.

In addition to working on lowering drug prices and bringing generic drugs to the market faster, both priorities for the Trump administration, Gottlieb has been a fierce advocate for a number of other public health issues, focusing the FDA’s attention on combating the opioid epidemic, creating harsher regulations for dietary supplements, and even “preserving Michelle Obama’s sugars labeling.”

Gottlieb had previously worked as a venture capitalist and board member for pharmaceutical companies, and made millions from his work in that industry, which caused alarm on the left when his appointment was originally announced. However, the commissioner surprised critics by divesting his interest in drug companies and calling for stronger and updated regulations across health-related industries.

Given his penchant for being chatty on Twitter, we rounded up some of the reactions to Gottlieb’s resignation from Bill of Health’s friends and family.

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