Commentary: Do We Really Need a New, More Powerful Opioid?

By Ron Litman

The FDA’s Analgesic and Anesthetic Drug Advisory Committee (AADPAC), of which I am a member, met October 12 to discuss a controversial New Drug Application (NDA) for a powerful opioid called sufentanil, manufactured by AcelRx.

Like fentanyl, sufentanil is a short-acting synthetic opioid, but approximately 5 to 10 times more potent. In the midst of the current opioid crisis, why would anyone think that the availability of another powerful opioid is a good idea?

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hand reaching for blue pills

The Rotten U.S. Antiparasitic Drug Market

Recently, there has been a lot of media attention on galling price hikes of generic drugs.

Historically, the social contract in pharmaceutical pricing has been tolerating expensive brand-name drugs while they have been on patent (a government-granted monopoly), followed by allowing low cost generics to rush to market after patent expiration. Yet these norms are now being challenged in the setting of increased generic manufacturer consolidation and single-source generic drugs.

Probably the most well known example is the case of Martin Shkreli (the so-called “Pharma Bro”) and Turing Pharmaceuticals, which bought out the rights of pyrimethamine (Daraprim), a key treatment for Toxoplasmosis and other infectious diseases, raising the price from $13.50 per pill to $750 per pill.

Note that even the pre-price hike price is significantly more than people other countries pay. In the UK it costs only $0.66 per pill and in Australia it is $0.18 per pill.

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two glasses of milk

The Cry Over Fake Milk

A debate has been brewing between the cattle milk industry and the plant-based milk industry (producing drinks made from ingredients such as almonds, soy, and rice), regarding what products can actually be labeled “milk.”

This has motivated the Federal Drug Administration to review how milk is defined under federal regulations, in order to protect public health and ensure that consumers are purchasing what they expect based on a product’s label.

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Count Your Calories, Says the FDA

By Nicholas J. Diamond

Fast Food emblems set on chalkboard. Hand drawn doodle style. Image via Thinkstock.

On May 7, a provision of the Affordable Care Act (ACA) relating to nutrition-labeling requirements finally went into effect, following three extensions to its compliance date by the U.S. Food and Drug Administration (FDA). In brief, under the requirements, most chain restaurants must now display calorie counts per serving on their menus. You may have already noticed that some of your favorite establishments have been ahead of the curve for awhile.

As I outline below, I broadly agree with the direction of the nutrition-labeling requirements, but highlight weaknesses and offer a way forward.

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The Notable Absence of Regulating Cannabis in FDA Commissioner Scott Gottlieb’s Keynote Address to FDLI 2018

by Tara Sklar

At the Food and Drug Law Institute (FDLI) 2018 Annual Conference, the Commissioner of Food and Drugs, Scott Gottlieb, gave the Keynote Address to kick-off the largest turnout yet for this event of over 900 attendees. Commissioner Gottlieb’s remarks started off with how previous FDA Commissioners used this opportunity to recap the past year, but he would be different, he would lay out the strategic priorities for next year.

The room went nearly silent, as Commissioner Gottlieb steadily went through the many sectors the agency oversees, and where he believes the FDA will play a larger leadership role, including in the epidemics of addition (opioid crisis), drug costs, and greater access to generic competition. He laid out a vision that most people in the room would probably subscribe to, including “You’re public health minded, and work hard to deliver innovations that’ll advance human health. The problem is that a few bad apples, that game the system, can tarnish the entire brand of an otherwise principled industry.”[1] Close to the end of his thirty-minute speech, Commissioner Gottlieb firmly addressed the companies that produce e-cigarettes, and said, “If you target kids, then we’re going to target you.”[2]

Indeed, Commissioner Gottlieb mentioned so many FDA strategic priorities, and in such unequivocal detail for how they plan to regulate, that when the President & CEO of the FDLI, Amy Comstock Rick, thanked him and introduced the follow-up panel to discuss the issues Commissioner Gottlieb raised, she said, “We reserved one-hour in the conference to discuss Commissioner Gottlieb’s Keynote Address, but we may need five.” However, there was an area that was not brought up in Commissioner Gottlieb’s wide-ranging speech, despite its very active place in the media and scientific journals calling for the FDA to have a greater role, and more consistent guidance, and this prominent area is the future regulation of cannabis. Read More

Was March a Turning Point for Tobacco Regulation in the U.S.?

By Nicholas J. Diamond

March was an important month for tobacco control in the U.S. While historically less progressive than other countries in regulating tobacco products, three recent developments offer encouraging signs of change. They also remind us of the critical role that the U.S. Food & Drug Administration (FDA) plays in public health policymaking.

The Three ANPRMs
Last month, the FDA released three advanced notices of proposed rulemaking (ANPRM) on tobacco-related products. An ANPRM is a formal invitation for stakeholders to submit comments before a federal agency issues a proposed rule. In practical terms, an ANPRM enables stakeholders to weigh in on, and even potentially shape, a forthcoming policy by responding to specific issues for input.

Released on March 16, the first ANPRM addresses the development of a tobacco product standard for a maximum nicotine level in cigarettes. The FDA seeks comment on a number of policy design considerations including, among others: the merits of various maximum nicotine levels (e.g., 0.5mg nicotine/g); to which products a maximum nicotine level should apply (e.g., combusted cigarettes, cigars, pipe tobacco); and whether to use a stepped-down, or gradual, reduction in maximum nicotine levels.

Importantly, the FDA highlights factors that could reduce the benefits of a future policy and seeks comment on how to addresses them. For example, current smokers could switch to a tobacco product not covered under the policy or use that non-covered product in addition to the currently used (covered) product. Similarly, current smokers could increase the number of cigarettes smoked to maintain an equivalent level of nicotine overall. Read More

Mass embryo destruction, reproductive never events, and the not-quite-Wild West

By Dov Fox

Information found in this new post by Dov Fox is also available in Slate’s March 19th article In Vitro Injuries: How should courts compensate would-be parents when assisted reproductive technology goes terribly wrong?

More than 1 in 10 Americans seek fertility treatment. IVF and similar technologies result in 64,000 babies—1.6% annually—of all those born in the U.S. each year. For people willing to move heaven and earth to form a family, this is the medicine of miracles. But reproductive mishaps turn these dreams into nightmares. Some result in unplanned pregnancies. Others, lost chances for parenthood. I’ve considered the legal complexities elsewhere at law review length. (A reply to critics Robert Rabin, Carol Sanger, and Gregory Keating is out shortly with Columbia.) But it’s the facts that have made headlines of late.

The Today Show and Nightly News interviewed me in the wake of recent storage tank malfunctions at two major fertility clinics—one in San Francisco, the other outside Cleveland—that destroyed more than 4,000 cryopreserved eggs and embryos. The Cleveland facility said that “alerts that should have been sent to staff were never sent.” These incidents have left over a thousand affected couples mourning future children who would never be; practitioners wondering how something like this could have happened; and prospective parents around the country worrying that tragedy could strike again.

It’s not the first time. NBC News uncovered a history of freezer malfunctions. Over a decade ago in Florida over 60 cancer survivors lost their stored sperm “when a tank made by the same manufacturer failed.” Exact figures for such breakdowns are hard to come by, however. Elsewhere in health care delivery, most states mandate reporting of “never events,” such as surgery on the wrong body part or patient. But the United State has no public or private system for tracking what I’ve referred to as “reproductive” never events, let alone less serious errors. So it’s impossible to know with any reliability or precision the incidence of professional mistakes in matters of procreation.

Available data points are bracing. A 2008 survey of nearly half of all U.S. fertility clinics found that more than one in five misdiagnosed, mislabeled, or mishandled reproductive materials. A 2014 study revealed that popular methods of prenatal screening for fetal abnormality sound “a false alarm half of the time.” And in 2016, a national ratings website found that 18-24% of fertility patients reported damaged or destroyed samples among a host of other errors.

None among regulators, agencies, insurers, medical boards, or professional societies require safeguards that might prevent mistakes like these from happening in the first place. The U.S. stands out among developed countries for its failure to rein in wrongdoing that forces parenthood on people who don’t want it or that denies it to those who do. In the United Kingdom, by contrast, a national agency requires that all facilities comply with a standard of professional conduct that covers “all details of the clinical and embryological practice associated with assisted reproductive technology.”

That agency—the Human Fertilisation and Embryology Authority—maintains rigorous laboratory inspections, often without notice. And even under its careful oversight, the agency reports that 1 out of every 100 fertility procedures—over 500 each year—involve reproductive materials that’s lost, damaged or destroyed. It stands to reason that these errors are at least as common in the United States, where fertility clinics, sperm banks, and surrogacy agencies aren’t monitored or supervised in any meaningful way. My own research uncovered hundreds of American cases in which procreation was negligently imposed, deprived, or confounded.

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Call for Papers: Wiet Life Sciences Scholars Conference

Loyola University Chicago’s nationally acclaimed Beazley Institute for Health Law and Policy is pleased to invite original research submissions for the annual Wiet Life Science Law Scholars Conference to be held on Friday, September 7, 2018.

The conference is designed to provide an intellectual venue for life science professors, scholars, and practitioners to convene and discuss current research and scholarship.  The phrase “life science law” intends to capture diverse disciplines that involve significant issues of life science research and development, spanning food and drug law, health law, intellectual property (IP) law, biotechnology law, environmental law, administrative law, and antitrust law.  Our goal is to foster recognition of life science law as a cohesive, dynamic area of legal study and strengthen connections among national life science law scholars.

Loyola is currently soliciting 750-1,000 word abstracts reflecting early or mid-stage ideas for the purpose of workshopping with other conference scholars.  Modeled after successful events for law professors and scholars in other areas, we will organize scholars in topical panels of three to five authors with approximately 15 minutes allotted to each abstract presentation, followed by 15 minutes of intensive discussion with scholar attendees.  Author abstracts will be distributed one week prior to the conference to scholar participants; authors may also submit draft articles for distribution.  Scholars are expected to review materials of fellow panel members.

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