Recent Developments in Off-Label Promotion

By Chris Robertson

July has been a busy month for those following the controversy around off-label promotion of drugs and devices.  As many on this blog know, federal law requires that prior to marketing any drug or device, companies must prove to the FDA’s satisfaction that it is safe and effective for all intended uses.  If the company reveals that it intends unapproved uses,  sales of the drug or device are illegal.  Nonetheless, physicians can prescribe “off-label,” and companies are free to sell for those known-but-not-intended purposes.

This carefully-wrought policy may seem convoluted, but it serves important epistemic and economic purposes, as I have argued elsewhere.  This month, I have a new draft paper on SSRN, assessing recent assertions of a First Amendment right to promote for uses not approved by the FDA, and consider whether such a right would be equally applicable to drugs that have no FDA-approved label at all. I worry that the entire pre-market approval regime may be at stake. Feedback on that intentionally-provocative analysis is quite welcome.

On Wednesday, two medical device company executives, were convicted of promoting a product “to deliver steroid medications to patients’ sinuses, though it was only approved by the U.S. Food and Drug Administration for keeping sinuses open.”  The prosecutors thought the case was particularly egregious, because the company had intended the broader use to deliver medicine all along, but sought to mislead the FDA, denying it the chance review the safety and efficacy of the real intended use.  The jury instructions and verdict form  are particularly interesting, to see how the government’s trial strategy avoids the holding of a Second Circuit case of Caronia, which overturned a conviction on First Amendment grounds.  I’ll return with some analysis later. Continue reading

Call for Proposals: BioIP Faculty Workshop

The American Society for Law, Medicine & Ethics (ASLME) is pleased to announce the second annual bioIP Faculty Workshop on May 5, 2017 at Loyola University of Chicago School of Law in Chicago, IL.

The Workshop offers a unique opportunity for three scholars in their first decade of teaching to present their work in progress for in-depth critique and commentary by respected senior scholars in the field.

Topics for the workshop are at the intersection of biotechnology, life sciences, food and drug law, and intellectual property (hence, bioip), broadly defined. A Review Committee comprised of faculty from the Boston University School of Law, Georgia State University College of Law, and the Loyola University Chicago School of Law will select papers for the Workshop in a blind process. Papers should present an original thesis and contribute to scholarly literature. The Workshop will not review published work.

Scholars with less than ten years of teaching experience, including VAPS and Fellows, are eligible for participation in the Workshop. Those interested in participating should submit an abstract (up to 750 words) of the proposed paper (without identifying details) along with a c.v. to Ted Hutchinson, Executive Director of the ASMLE at thutchinson@aslme.org by Oct 14, 2016.

Selected abstracts will be announced later in Fall 2016 with the full draft papers due by April 1, 2017. The organizers will cover reasonable travel and lodging expenses for selected scholars.

For questions, please email Cynthia Ho at cho@luc.edu.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.

Below are the papers identified from the month of June. The selections feature topics ranging from lessons from the history of randomized controlled trials, to the prevalence and predictors of generic drug skepticism among physicians, to the availability and dissemination of results from FDA-mandated post-approval studies of medical devices. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Bothwell LE, Greene JA, Podolsky SH, Jones DS. Assessing the Gold Standard–Lessons from the History of RCTs. N Engl J Med. 2016;374(22):2175-81.
  2. Gellad WF, Good CB. Prescription of Brand-Name Medications When Generic Alternatives Are Available-Patently Unfair. JAMA Intern Med. 2016 Jun 27. [Epub ahead of print]
  3. Hwang TJ, Sokolov E, Franklin JM,  Kesselheim AS. Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study. BMJ. 2016;353:i3323.
  4. Ioannidis JP. Why Most Clinical Research Is Not Useful. PLoS Med. 2016;13(6):e1002049.
  5. Kesselheim AS, Gagne JJ, Eddings W, Franklin JM, Ross KM, Fulchino LA, Campbell EG. Prevalence and Predictors of Generic Drug Skepticism Among Physicians: Results of a National Survey. JAMA Intern Med. 2016;176(6):845-7.
  6. Kesselheim AS, Gagne JJ, Franklin JM, Eddings W, Fulchino LA, Avorn J, Campbell EG. Variations in Patients’ Perceptions and Use of Generic Drugs: Results of a National Survey. J Gen Intern Med. 2016;31(6):609-14.
  7. Luo J, Seeger JD, Donneyong M, Gagne JJ, Avorn J, Kesselheim AS. Effect of Generic Competition on Atorvastatin Prescribing and Patients’ Out-of-Pocket Spending. JAMA Intern Med. 2016 Jun 27. [Epub ahead of print]
  8. Moore TJ, Furberg CD, Mattison DR, Cohen MR. Completeness of serious adverse drug event reports received by the US Food and Drug Administration in 2014. Pharmacoepidemiol Drug Saf. 2016 Jun;25(6):713-8.
  9. Quesada O, Yang E, Redberg RF. Availability and Dissemination of Results From US Food and Drug Administration-Mandated Postapproval Studies for Medical Devices. JAMA Intern Med. 2016 Jun 27. [Epub ahead of print]
  10. Sarpatwari A, Kesselheim AS. Navigating the Dermatological Drug Cost Curve. JAMA. 2016;315(24):2724-5.
  11. Sarpatwari A, Avorn J, Kesselheim AS. State Initiatives to Control Medication Costs–Can Transparency Legislation Help? N Engl J Med. 2016;374(24):2301-4.
  12. Schwartz LM, Woloshin S, Zheng E, Tse T, Zarin DA. ClinicalTrials.gov and Drugs@FDA: A Comparison of Results Reporting for New Drug Approval Trials. Ann Intern Med. 2016 Jun 14. [Epub ahead of print]

Are The FDA’s New Definitions And Labeling Requirements Good For Us, Or Just Empty Calories?

By Diana R. H. Winters

[Crossposted from the Health Affairs Blog]

The Food and Drug Administration (FDA) has recently taken three steps toward providing consumers with more and better information about food products that the agency regulates. First, in response to several citizen petitions, the agency requested comments on the use of the term “natural” on food labeling. Second, the agency issued a statement in early May indicating that “in the near future” it planned to solicit comments reevaluating how nutrient content claims are regulated — including the term “healthy.” And third, the agency issued a final rule on an updated Nutrition Facts label, with which large companies must comply by July 2018.

With each of these actions the FDA is attempting to ensure that information provided to consumers by food manufacturers comports with the latest scientific understanding about food components. Indeed, the updated nutrition facts label will provide important information and potentially allow consumers to make more informed choices about what they eat. The agency, however, has set itself a far trickier task in defining words such as “natural” and “healthy.”

Act Naturally

In the past, the FDA has repeatedly declined to define the term “natural.” The Nutrition Labeling and Education Act (NLEA) of 1990 required the FDA to standardize definitions for nutrient content claims, like “fat free” or “high in fiber,” and to limit the use of health claims, like “heart healthy” (21 U.S.C. §§ 343(r)(1)(A), (B)). The word “natural,” however, does not fit into either of these categories.

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New Resource: BPCIA Legislative History Documents

The Petrie-Flom Center is pleased to announce the availability of a new resource on its website: the legislative history of the Biologics Price Competition and Innovation Act (BPCIA).  The BPCIA, passed as part of the Affordable Care Act (ACA), created a pathway for the approval of biosimilar products and awarded innovator biologic companies twelve years of exclusivity for their products.  Modeled after the Hatch-Waxman Act of 1984, which established our system of generic small-molecule drug approvals while simultaneously creating a five-year period of exclusivity for new drugs, consideration of the BPCIA’s history is often lost in the discussion over the ACA’s history as a whole.  This resource selects only those documents relating to the BPCIA and may thus prove particularly useful for scholars of FDA law.

This new resource comes at an opportune time, as the courts and Congress have both turned their focus to the provisions of the BPCIA.  In 2015, the Federal Circuit issued a divided opinion interpreting the BPCIA’s instructions to biosimilar and innovator drug sponsors, and that opinion has now been appealed to the Supreme Court.  Just last month, the Justices called for the views of the Solicitor General on this question, a step which may significantly increase the likelihood of an eventual cert grant.  At the same time, several members of Congress have introduced a bill that would decrease the BPCIA’s grant of exclusivity from twelve years to seven years, bringing it more in line with the five-year period in the Hatch-Waxman Act or seven-year period in the Orphan Drug Act.  The twelve-year period of exclusivity may have been the most contentious aspect of the BPCIA as passed, with even the FTC arguing strongly against such a lengthy period at the time.

Members of the public may also be interested in an article written by Professor Erika Lietzan and colleagues providing an excellent analysis of the BPCIA’s legislative history.

Trial by Fire: CRISPR takes the next step

CRISPR-Cas9 has drawn applause for being one of the biggest technological advancements in recent history, but it also raises important ethical issues. This technology, an efficient genome editing tool, is now taking its next big step: CRISPR might be going in for human trials for its potential use in fighting cancer (namely, by altering T-cells to treat cancer cells as “foreign bodies”). Trials have been proposed to be conducted at three sites over a period of two years. The Recombinant DNA Advisory Committee (RAC) at the NIH gave its unanimous approval for these trials earlier this week. Now permissions from FDA and Institutional Review Boards remain before this becomes a reality.

Whether or not the studies will get that approval is uncertain. The RAC already expressed concerns about conflict of interest, and the ghosts of the trial involving Jesse Gelsinger 17 years ago at UPenn have resurfaced.  There are also important questions about risks, uncertainty, and informed consent from the research participants.

The scientific community and regulators have been wary of the gravity of the implications of genome editing. When a Chinese study involving gene editing in human embryos was submitted for publication, there was a hue and cry over whether journals should accept it, given ethical concerns. Currently, there is a moratorium on altering DNA that will subsequently pass on to new generations. Even when the CRISPR technology was approved for editing human embryos in the UK, it was mandated that embryos be destroyed within fourteen days.

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The Catch-22 of Bayh-Dole March-In Rights

Earlier today, the NIH rejected a request filed by consumer groups including Knowledge Ecology International (KEI) to exercise the government’s march-in rights on an expensive prostate cancer drug, Xtandi.  Xtandi costs upwards of $129,000 per year, and KEI had asked the government to exercise its rights under the Bayh-Dole Act, which specifies a range of conditions under which the government may require a patentholder to grant licenses on reasonable terms to others to practice the patent.  Specifically, the government may require such a license where “action is necessary to alleviate health or safety needs which are not reasonably satisfied,” 35 U.S.C. § 203(a)(2), or where the benefits of the invention are not being made “available to the public on reasonable terms,” 35 U.S.C. § 201(f).

For some time now, there has been debate over the question of whether high prices for pharmaceuticals are a sufficient trigger to invoke the use of march-in rights under these clauses of the statute.  I don’t take a position on that question here.  Instead, I want to ask whose responsibility it is to decide that question.  Congress has the legal right to do so, but it seems unwilling or unable to.  The agencies in question have recently declined to, even assuming they have the power to interpret the statute in that way.  And so we might look to the courts.  But there’s a puzzle here: it’s not clear that anyone can ask a court to decide whether high prices meet the statutory requirements unless an agency actually decides that high prices meet the statutory requirements.

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Thoughtful CREATES Act May Help Speed Generic Drug Approvals

Earlier this week, a bipartisan group of Senators introduced the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, a bill designed to speed generic drug approvals (and thus lower drug costs) by removing a delaying tactic some branded drug companies use to impede the generic approval process.  Essentially, branded drug companies sometimes refuse to sell samples of their drugs to generic companies who want to come to market, preventing them (for at least a time) from performing the necessary bioequivalence testing and extending their market dominance.  Sometimes companies try to hide behind a regulatory program, Risk Evaluation or Mitigation Strategies (REMS), in claiming that they legally cannot provide such access.  Other times, such as in Martin Shkreli’s case, no such excuse exists and the company simply refuses to provide access.

These delaying tactics have received substantial attention from both scholars (Jordan Paradise’s work can be found here) and lawmakers.  This is Congress’ third attempt at addressing the situation, although as Ed Silverman helpfully notes at Pharmalot, the previous attempts would have only dealt with REMS delays, not Shkreli-like closed distribution systems.  By contrast, the CREATES Act would require brand-name companies to provide access to samples of their drugs, whether subject to a REMS or not, on “commercially reasonable, market-based terms” or face potential civil action from the generic drug company in question.  There’s already been a lot of commentary on the bill, including a particularly helpful blog post from Geoffrey Manne providing background on REMS abuses and on why antitrust law has not sufficed to solve the problem.  Here, I want to add two points that I haven’t yet seen in the discussion: one about drug shortages and another about remedies.

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Rachel Sachs on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week we spoke with Rachel E. Sachs, who will join the faculty of the Washington University in St. Louis School of Law in Fall 2016. Rachel earned her J.D. in 2013 magna cum laude from Harvard Law School, where she was the Articles Chair of the Harvard Law Review and a student fellow with both the Petrie-Flom Center and the John M. Olin Center for Law, Economics, and Business. Rachel has also earned a Master of Public Health from the Harvard School of Public Health. We focused on Rachel’s work on drug pricing and innovation for global health. As part of a broader academic agenda for developing access to knowledge, Rachel’s work illuminates the many trade-offs involved in optimizing innovation law. She has also illuminated the importance of “innovation beyond IP,” and the importance of legal synergies in accelerating or impeding innovation.

Listen here! The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.

Below are the papers identified from the month of May. The selections feature topics ranging from a review of progress in the fight against multidrug-resistant bacteria, to the role regulators can play in increasing the affordability of drugs, to an assessment of the strength of the surrogate-survival relationship for cancer drugs approved on the basis of surrogate endpoints. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Deak D, Outterson K, Powers JH, Kesselheim AS. Progress in the Fight Against Multidrug-Resistant Bacteria? A Review of U.S. Food and Drug Administration-Approved Antibiotics, 2010-2015. Ann Intern Med. 2016 May 31. [Epub ahead of print]
  2. Eichler HG, Hurts H, Broich K, Rasi G. Drug Regulation and Pricing–Can Regulators Influence Affordability? New Engl J Med. 2016 May 12;374(19):1807-9.
  3. Hey SP, Weijer C. What questions can a placebo answer? Monash Bioeth Rev. 2016 May 17. [Epub ahead of print]
  4. Kapczynski A, Kesselheim AS. ‘Government Patent Use’: A Legal Approach To Reducing Drug Spending. Health Aff. 2016 May 1;35(5):791-7.
  5. Kim C, Prasad V. Strength of Validation for Surrogate End Points Used in the US Food and Drug Administration’s Approval of Oncology Drugs. Mayo Clin Proc. 2016 May 10. [Epub ahead of print]
  6. Outterson K, McDonnell A. Funding Antibiotic Innovation With Vouchers: Recommendations On How To Strengthen A Flawed Incentive Policy. Health Aff. 2016 May 1;35(5):784-90.
  7. Patel MS, Day SC, Halpern SD, Hanson CW, Martinez JR, Honeywell S Jr, Volpp KG. Generic Medication Prescription Rates After Health System-Wide Redesign of Default Options Within the Electronic Health Record. JAMA Intern Med. 2016 May 9. [Epub ahead of print]
  8. Yeh JS, Franklin JM, Avorn J, Landon J, Kesselheim AS. Association of Industry Payments to Physicians With the Prescribing of Brand-name Statins in Massachusetts. JAMA Intern Med. 2016 May 9. [Epub ahead of print]

NPRM Symposium: Quick Take on New Analysis of the Comments on the NPRM to Amend the Common Rule (and the Challenge for Bioethics and the Public)

The Council on Governmental Relations (COGR), with support from the Association of Public and Land-grant Universities (APLU), undertook “to review and analyze the 2,186 public comments submitted in response to the 2015 Federal Policy for the Protection of Human Subjects” or “Common Rule” Notice of Proposed Rulemaking (NPRM).

I am going to discuss some highlights of their just released report, but this is far from exhaustive and you should read the whole report.

For the non-cognoscenti this is the most important revision to the rules for U.S. human subjects research since their inception. The report is largely unfavorable to several key proposed rule changes on my first read, but you should read it yourself to make up your own mind.

I’ll share some choice passages from the analysis

The results of our review (Table 2) find significant opposition to most major proposals, with mixed support for mandated use of a single IRB and extending the Common Rule and greater support for the concept of standard security safeguards. In addition, a number of responses suggested that the NPRM is overly complex, poorly written, and not supported by data; highlighted areas that could have a substantial impact on a final rule but were not included in the NPRM (e.g., proposed security safeguards, a consent template, a list of minimal risk studies and a decision tool); and suggested that some of the proposals would adversely affect human health with little perceived benefit.

Turning to Biospecimens, where we had a conference last year that will soon generate a book with MIT press:

The majority of responses, approximately 1,520, addressed one or more of the proposed changes detailed above involving non-identified biospecimens. Of these responses, 94 – 100% of patients and members of the research community, including researchers, universities, medical centers and industry, opposed the changes. Those commenting suggested that the proposed changes will significantly reduce the availability of biospecimens for research, will have a significant negative impact on medical advances, and will adversely affect human health. Per one patient, “I am asking for life saving policy not life ending policies.” From a biorepository, “Respecting autonomy at the expense of patient lives is a significant ethical concern.”

More surprising was their finding that “Among members of the general public, 55% opposed and 45% supported one or more of the major proposed changes related to biospecimens.” (They do a better breakdown of the various sub-constituencies in the report).

Turning to “broad consent” for biospecimen use:

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Call for Proposals: Innovations in Life Sciences and Stakeholder and Agency Responses

The Beazley Institute for Health Law and Policy at Loyola University Chicago School of Law and Annals of Health Law invite original research paper submissions on innovations in life sciences and stakeholder and agency responses for presentation at our Tenth Annual Health Law Symposium. The Symposium will take place at Loyola University Chicago School of Law on Friday, October 28, 2016 at 9:30am.

The Symposium will explore recent innovations in life sciences and responses by regulatory agencies including FDA, FTC, and DOJ as well as stakeholder responses and recommended next steps for policy and regulatory reforms.

A range of topics will be considered, including but not limited to gene editing, mobile health,
cybersecurity, personalized/precision medicine, 3-D printing technologies, Cancer Moonshot 2020, biosimilars and interchangeable biologics, and vaccine development and incentives (e.g., Zika).

Submission Information: Those interested in participating, please send a 1000-word abstract to  health-law at luc.edu by May 31, 2016. Authors will be notified of decisions no later than June 15, 2016. If your abstract is selected, a full paper will be due by January 6, 2017.

Covered expenses: Hotel, travel, ground transportation, three provided meals.

Questions: E-mail questions to health-law@luc.edu Continue reading

What do doctors know about FDA drug approval standards and the breakthrough therapy designation? Less than we’d hope.

By Dalia Deak

A study published this week in JAMA examined how much physicians know about FDA approval standards for new drugs and the breakthrough therapy designation. The investigators found major gaps in understanding with regard to both issues, despite intuitive beliefs to the contrary.

For the study, Kesselheim et al. conducted a national survey of board-certified internists and specialists. They selected a random sample of 300 clinically active internists and 900 specialists in endocrinology, hematology, and infectious diseases from the American Board of Internal Medicine’s diplomate list. Of the 1,148 physicians contacted, 692 physicians, or 60%, responded.

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Virginia’s Proposed Lethal Injection Secrecy Law

By Elizabeth Guo

On Monday, Governor Terry McAuliffe of Virginia proposed a significant change to the Virginia legislature’s bill to replace lethal injection with electrocution in death penalty cases. Instead of allowing electrocution, the amendment would give greater authority to the Department of Corrections (DOC) for procuring and making lethal injection drugs. Under the proposed amendments, the DOC could contract with a pharmacy to compound drugs necessary to carry out lethal injection. The amendments would also keep the names of drug suppliers and compounders secret by exempting the information from the Freedom of Information Act. Also, the names would not be discoverable “in any civil proceeding unless good cause is shown.”

States with capital punishment are increasingly resorting to state secrecy laws as they are finding it harder to procure the lethal injection drugs they need. At least fourteen states have passed or tried to pass rules keeping the names of lethal injection suppliers confidential. Some states, such as Georgia, define information about the drugs and equipment used in an execution as a “confidential state secret” so that the public prisoners and even courts are prevented from viewing the information. Other states, including Oklahoma, do not designate this information as a state secret but nonetheless, make the information unavailable through litigation. A few states allow litigants to discover the information through litigation, but the state does not need to make the information publicly available.

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Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.

Below are the papers identified from the month of March. The selections feature topics ranging from the characteristics and follow-up of post-marketing studies or conditionally authorized medicines in the European Union; to changes in prescription drug, over the counter drug, and dietary supplement use among older adults in the United States; to an assessment of the logic of Amarin’s off-label promotion of Vascepa. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Hey SP, Kesselheim AS. An Uninformative Truth: The Logic of Amarin’s Off-Label Promotion. PLoS Med. 2016 Mar 15;13(3):e1001978.
  2. Hoekman J, Klamer TT, Mantel-Teeuwisse AK, Leufkens HG, De Bruin ML. Characteristics and follow-up of post-marketing studies of conditionally authorised medicines in the EU. Br J Clin Pharmacol. 2016 Mar 18. [Epub ahead of print].
  3. Kapczynski A. Free Speech and Pharmaceutical Regulation-Fishy Business. JAMA Intern Med. 2016 Mar 1;176(3):295-6.
  4. Massey PR, Wang R, Prasad V, Bates SE, Fojo T. Assessing the Eventual Publication of Clinical Trial Abstracts Submitted to a Large Annual Oncology Meeting. 2016 Mar;21(3):261-8.
  5. Qato DM, Wilder J, Schumm LP, Gillet V, Alexander GC. Changes in Prescription and Over-the-Counter Medication and Dietary Supplement Use Among Older Adults in the United States, 2005 vs 2011. JAMA Intern Med. 2016 Mar 21. [Epub ahead of print]
  6. Yeh JS, Sarpatwari A, Kesselheim AS. Ethical and Practical Considerations in Removing Black Box Warnings from Drug Labels. Drug Saf. 2016 Mar 21. [Epub ahead of print]

Additional Troubles for Theranos

By Katherine Kwong

The onslaught of bad news for Theranos, the start-up laboratory services company plagued with troubles since last October, continued this week with a new round of reports and press coverage. First, on March 28, the Journal of Clinical Investigation published an article that found that Theranos’ tests tended to produce more irregular results than those of two other laboratory services companies. Then, on March 31, an inspection report by the Centers for Medicare and Medicaid Services was released, revealing numerous problems at Theranos that led to quality control problems, possibly leading to inaccurate test results for patients. The article and report both raise additional questions about Theranos’ claims and long-term viability – a steep letdown from early hype about the company, which promised to revolutionize the laboratory testing industry. The story of Theranos’ troubles highlights how scientific flaws and regulatory mishaps can lead to serious problems for companies seeking to innovate in the health sciences space.

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FDA’s Relationship with Marijuana: It’s Complicated

By Elizabeth Guo

Marijuana and marijuana-derived products are top of mind for state legislatures these days. On March 10, the Virginia state legislature passed a bill legalizing cannabidiol oil, a marijuana-derived product, for patients who suffer from epilepsy. Other legislatures are actively debating measures to legalize cannabis-related products in their states, and many of these legislative proposals would allow cannabis-use for patients suffering from specific medical conditions. Last week, the Alabama state legislature debated a bill that would allow people to take cannabidiol to treat certain conditions, and Utah recently defeated a bill that would have allowed people with certain debilitating conditions to use a marijuana-related extract.

As more states pass bills allowing patients to use marijuana-derived products, will state laws clash with federal policies implemented by the Food and Drug Administration (FDA)?

Marijuana is complicated. Marijuana refers to the dried leaves and flowers of the cannabis plant. All marijuana plants contain a mixture of molecules, including cannabinoids. Different cannabinoids can have different effects, and scientists have identified more than 200 different cannabinoids from marijuana plants. Some of the most well known cannaboids in marijuana include tetrahydrocannibonol (THC), cannabidiol (CBD), and archidonoyl ethanolamide (anandamide). Continue reading

Regulating genetically modified mosquitoes

By Dalia Deak

Fears of spreading zika virus have renewed interest in the use of genetically modified mosquitoes to suppress disease, with recent attention focused on the UK firm Oxitec. Last week, the developing public health crisis around zika prompted the federal government to tentatively clear a small-scale field test for the first time in the United States, pending a public comment process on a draft environmental assessment submitted by Oxitec. It should be noted that a final approval for the trial will not be made until the FDA completes the public comment process.

The genetically modified insects, which are male Aedes aegypti mosquitoes, are designed to breed with the female Aedes aegypti mosquito (primarily responsible for transmitting zika, dengue fever, and other diseases) and contain a gene lethal to their offspring. The female mosquitoes lay eggs but the larvae die well before adulthood. Oxitec claims that recent tests have shown up to a 90% decrease in the population of the Aedes aegypti mosquito, with a recent test in Piracicaba (~100 miles from Sao Paulo in Brazil) showing an 82% decline. Tests have also been conducted in the Cayman Islands and Malaysia.

In the United States, Oxitec is in the process of waiting for FDA approval to conduct trials in the Florida Keys. However, this is relatively unclear and uncharted territory for the federal government in terms of what group should be responsible for the review, and the decision for the CVM jurisdiction in this case remains hotly debated. Jurisdictional debate exists between the U.S. Department of Agriculture and the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Veterinary Medicine (CVM).

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TOMORROW, 3/25 in NYC! Book Talk & Panel: FDA in the 21st Century – The Challenges of Regulating Drugs and New Technologies

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FDA in the 21st Century:
The Challenges of Regulating Drugs and New Technologies

March 25, 2016 12:00 PM

92nd Street Y
1395 Lexington Ave. (at 92nd St.), New York, NY

Join co-editors Holly Fernandez Lynch (Petrie-Flom Executive Director) and I. Glenn Cohen (Petrie-Flom Faculty Director) and contributor Lewis Grossman (American University) for a discussion of FDA in the 21st Century: The Challenges of Regulating Drugs and New Technologies (Columbia University Press, 2015). This volume stems from the Center’s 2013 annual conference, which brought together leading experts from academia, government, and private industry to evaluate the FDA and to begin charting a course for the agency’s future.

This is a ticketed event. To learn more, visit the 92nd Street Y’s website!

Sponsored by the 92nd Street Young Men’s and Young Women’s Hebrew Association (New York, New York) and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Zubik v. Burwell, Part 3: Birth Control Is Not Abortion

Photo: Plan B

Flickr/Creative Commons—Irina Ivanova

By Gregory M. Lipper

(Read Part 1Part 2Part 4Part 5, and Part 6 of this series)

Pay attention to the Supreme Court’s upcoming contraceptive-coverage cases and you’ll hear horror stories from religious-right groups about an “abortion-pill mandate” (here’s ADF and ACLJ). These groups know that contraception is popular and that, to most people, campaigns to block birth control would seem Jurassic. With abortion more controversial, claims about compulsory distribution of “abortion pills” sound much scarier. Indeed, the plaintiffs’ briefs in Zubik claim that the accommodation would make the plaintiffs complicit in the provision of coverage for, among other things, “abortifacients.”

But neither surgical abortion nor the abortion pill (known as RU–486) are part of the Affordable Care Act’s coverage requirements. So why are courts, websites, and inboxes awash in complaints about the termination of pregnancies?

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