Health

Health in the Fast Lane: FDA’s Effort to Streamline Digital Health Technology Approval

October 7, 2017
FDA, Health, Regulatory, Uncategorized

Alex Eschenroeder, MJLST Staffer

The U.S. Food and Drug Administration (FDA) is testing out a fast-track approval program to see if it can accommodate the pace of innovation in the technology industry and encourage more ventures into the digital health technology space. Dr. Scott Gottlieb M.D., Commissioner of the FDA, announced the fast-track pilot program—officially named the “Pre-Cert for Software Pilot Program” (Program)—on July 27, 2017. Last week, the FDA announced the names of the nine companies it selected out of more than 100 applicants to participate in the Program. Companies that made it onto the participant list include tech giants such as Apple and Samsung, as well as Verily Life Sciences—a subsidiary of Alphabet, Inc. The FDA also listed smaller startups, indicating that it intends to learn from entities at various stages of development.

The FDA idea that attracted applicants from across the technology industry to the Program is roughly analogous to the TSA Pre-Check Program. With TSA Pre-Check certification, travelers at airports get exclusive access to less intensive pre-boarding security procedures because they submitted to an official background check (among other requirements) well before their trip. Here, the FDA Program completes extensive vetting of participating technology companies well before they bring a specific digital health technology product to market. As Dr. Gottlieb explained in the July Program announcement, “Our new, voluntary pilot program will enable us to develop a tailored approach toward this technology by looking first at the . . . developer, rather than primarily at the product (as we currently do for traditional medical products).” If the FDA determines through its review that a company meets necessary quality standards, it can pre-certify the company. A pre-certified company would then need to submit less information to the FDA “than is currently required before marketing a new digital health tool.” The FDA even proposed the possibility of a pre-certified company skipping pre-market review for certain products, as long as the company immediately started collecting post-market data for FDA to confirm safety and effectiveness.

While “digital health technology” does not have a simple definition, a recently announced Apple initiative illustrates what the term can mean and how the FDA Program could encourage its innovation. Specifically, Apple recently announced plans to undertake a Heart Study in collaboration with Stanford Medicine. Through this study, researchers will use “data from Apple Watch to identify irregular heart rhythms, including those from potentially serious heart conditions like atrial fibrillation.” Positive research results could encourage Apple, which “wants the Watch to be able to detect common heart conditions such as atrial fibrillation”, to move further into FDA regulated territory. Indeed, Apple has been working with the FDA, aside from the Program, to organize the Heart Study. This is a critical development, as Apple has intentionally limited Watch sensors to “fitness trackers and heart rate monitors” to avoid FDA regulation to date. If Apple receives pre-certification through the Program, it could issue updates to a sophisticated heart monitoring app or issue an entirely different diagnostic app with little or no FDA pre-market review. This dynamic would encourage Apple, and companies like it, to innovate in digital health technology and create increasingly sophisticated tools to protect consumer health.

Artificial Wombs and the Abortion Debate

September 12, 2017
Health, New Technology, Reproductive Health

Henry Rymer, MJLST Staffer

In a study published in the latter part of April 2017, a group of scientists reported that they had created an “extra-uterine system” that assisted in the gestation, and eventual birth, of several fetal lambs. This device, which houses the fetus in a clear plastic bag, is filled with a synthetic amniotic fluid that flows in and out of the bag through a pump system. While inside this artificial womb, the fetus is attached to a machine outside of the bag by its umbilical cord. This machine is used for several purposes: providing nutrition to the fetus, giving the fetus necessary medication, providing the blood of the fetus with a blend of air, oxygen and nitrogen, and removing carbon dioxide from the bloodstream. The scientists report that in housing the premature lamb fetuses in this system, the scientists were able to “maintain stable haemodynamics, have normal blood gas and oxygenation parameters, and maintain patency of the fetal circulation” within the fetuses. Additionally, the scientists report that the fetal lambs subject to this test were able to demonstrate “normal somatic growth, lung maturation and brain growth and myelination.” The scientists’ report that they believe that this extra-uterine system would not be relegated only to animal use, as they believe that the device could support a premature human infant “for up to four weeks.”

With the advent of this new piece of neonatal technology, specifically with the implications of what this invention (and others like it) would have on fetal development for humans, the artificial womb poses the power to completely shift the paradigm in regards to how the abortion debate is framed. In particular, the impact that this invention will have when combined with American jurisprudence will surely be a new point of contention between Pro-Abortion activists and their Anti-Abortion counterparts.

With the Supreme Court case of Planned Parenthood v. Casey, SCOTUS re-enshrined the thesis of Roe v. Wade: namely that women have the right to have an abortion prior to the viability of the fetus. Planned Parenthood of Southeastern Pa. v. Casey, 505 U.S. 833, 846. The Casey court also stated that states have the power to “restrict abortions after fetal viability, if the law contains exceptions for pregnancies which endanger the woman’s life or health” and that the “State has a legitimate interest from the outset of the pregnancy in protecting the health of the woman and the life of the fetus that may become a child.” Id.

The arguments that arise from the advent of an artificial womb in conjunction with case law flows from the notion of what a “viable” fetus would be after extra-uterine systems become more mainstream and sophisticated. If these machines develop to a point in which they can take a fetus the moment after conception and develop it for its entire gestation period, will abortion procedures become completely outlawed? Will “viability” remain the measure by which a fetus is distinguished from a human, or will a new metric be invented to replace “viability?” Additionally, will this be a problem that the courts will have to answer? The legislature? Or a combination of both? The invention of artificial wombs seems to be a periphery legal issue that will not have to be answered for some time yet. However, there are many questions that need to be answered as technology improves and develops, and the abortion debate will not be a topic that will remain untouched as humanity moves into the future.

A Different Kind of Egg For Easter: Scientific Proof of Fetal Pain and the Legal Right to Choose Abortion

April 7, 2017
Ethics, Health, Reproductive Health

Angela Fralish, MJLST Invited Blogger

On January 3, 2017 Congressman Trent Franks from Arizona suggested a major change in the law which could overturn precedent of more than 30 years. He introduced the “Pain-Capable Unborn Child Protection Act” which generally prohibits abortions after 20 weeks. Fueling this highly controversial legislation is a complex scientific and legal debate as to whether or not the fetus can feel pain at 20 weeks, and if that proof should result in a change in the law.

Advocates on both sides of the Act include physicians, legislators, constitutional law experts, policy interest groups, philosophers and neuroscientists. Supporters of non-interference prior to viability advocate that proof of fetal pain is not substantiated. One the other side, fetal pain protestors argue that a fetus can in fact feel pain at 20 weeks, and abortions should be proscribed between after that time.

The Supreme Court ruled in watershed cases Roe v. Wade (1973), and Planned Parenthood v. Casey (1992), that a woman’s right to elect an abortion prior to viability, which is usually 23 to 24 weeks, is a constitutionally protected “fundamental right.” Time and time again, the Supreme Court has upheld that precedent, and prevented the right to interfere with a woman’s choice prior to viability. However, new medical technology advances call the old law into question. As Supreme Court Justice Sandra Day O’Connor noted in Roe, medical science will reduce the point of viability and “Roe is clearly on a collision course with itself.”

Scientifically speaking, both parties have referenced the anatomical makeup for fetal pain to support their arguments. Studies show that the thalamus and pain sensor receptors, usually developed by 20 weeks, are used to process pain. The counter argument is that the anatomical capability to feel pain does not equate to actually feeling pain: fetuses at 20 weeks lack the necessary pain pathways, or physiological ability to communicate pain, even if the thalamus and receptors are available. Legislative findings of the Pain-Capable Unborn Child Protection Act argue that fetuses at 20 weeks not only respond to touch, but also emit stress hormones and recoil at painful stimuli. Thus, some have concluded that fetuses are indeed “capable” of feeling pain and abortion should be proscribed at that time.

So where should the court draw the line? One past example of legislation related to medical uncertainty related to fetal pain was the Partial Birth Abortion Act of 2003. After much controversy, this act was upheld by Gonzalez v. Carhart (2007) noting that “medical uncertainty does not foreclose the exercise of legislative power in the abortion context any more than it does in other contexts.” In this sense, Congressman Trent Franks’ bill could potentially pass, despite long held precedent, because the courts retain legislative power within the abortion context when there is medical uncertainty. However, much like the Partial Birth Abortion Act, if Congress passes this legislation, it will be up to the state courts and modern day legal advocates to reinforce or discredit it on a case-by-case basis.

Only time will tell how this intricately webbed science-law issue will play out. Judith Munson quoted as early as 1975 in her article Fetal Research: A View from Right to Life to Wrongful Birth, “The controversy has become a contest between the state of the art and the state of the law.” Constitutional lawyers, physicians and the general public certainly have their work cut out for them in understanding how medical science impacts the law. As O.D. Jones remarks, “Law and neuroscience seem strange bedfellows. But the engagement of law with neuroscientific evidence was inevitable.” This holds especially true in relation to mother chicks and decisions regarding their “eggs.”

No Divorce Just Yet, But Clearly This Couple Has Issues: Medicaid and the Future of Federal-State Health Policy

March 28, 2017
Health, Healthcare, Healthcare Reform, Insurance

Jordan Rude, MJLST Staffer

With the recent demise of the American Health Care Act (AHCA), the Affordable Care Act (ACA) will remain in effect, at least for now. One of the crucial issues that divided the Republican caucus was Medicaid—specifically, whether the ACA’s expansion of Medicaid should remain in place or be rolled back (or eliminated entirely). Moderate or centrist Republicans, and particularly some Republican governors, wanted to retain the expansion, while the House Freedom Caucus and other conservatives wanted to eliminate it, either immediately or in the near future.

Sara Rosenbaum, in her article Can This Marriage Be Saved? Federalism and the Future of U.S. Health Policy Under the Affordable Care Act examined the changing relationship between federal and state health policy under the ACA. Two areas in which this relationship was most affected were the ACA’s health insurance marketplaces and expansion of Medicaid: In both, the ACA significantly increased the federal government’s role at the expense of state control. The Supreme Court’s ruling in National Federation of Independent Business v. Sebelius held that the federal government could not require states to expand their Medicaid coverage, pushing back against increased federal power in this area. As of today, approximately 20 states have taken advantage of this ruling and chosen not to expand their programs. Rosenbaum argued that the tension between the ACA’s promise of universal coverage and some states’ refusal to expand Medicaid would defeat the purpose of the ACA, and she proposed a federal “Medicaid fallback” to replace lost coverage in those states.

The AHCA proposed a different, and simpler, solution to this problem—phase out the Medicaid expansion over time until it is completely gone. As noted above, this did not have much of a positive reception. Now that the AHCA’s proposal has been shelved, if only momentarily, some states that had not previously expanded Medicaid (such as Kansas) are moving forward with plans to expand it now. Such plans still face stiff opposition from conservatives, but the failure of the AHCA, along with the ACA’s growing popularity, may shift the argument in favor of expansion.

The end result of this recent healthcare debate, however, was retention of the status quo: The ACA is still in effect, and a significant number of states have still not expanded Medicaid coverage. The underlying issue that Rosenbaum discussed in her article has still not been addressed. The clash between federal and state policy continues: The marriage is not over, but it is not clear whether it can be saved.

This Time It’s Personal(ized): Pharmaceutical Companies, Dosing Regimen Patents, and Personalized Medicine

March 20, 2017
Health, Healthcare, Patents

Peter Selness, MJLST Staffer

An area of developing healthcare garnering attention in both the medical community and areas of intellectual property law is that of personalized medicine. Personalized medicine changes the old one-size-fit-all approach of medication dosing to instead tailor medications to each individual patient based upon their genetic make-up. This practice promises numerous benefits for patient healthcare, but also has some substantial road blocks to overcome before becoming a reality. Among the issues facing this field of medicine is the controversy surrounding the patentability of personalized medicine methods. Several recent cases such as Mayo Collaborative Services v. Prometheus Laboratories and Association for Molecular Pathology v. Myriad Genetics, Inc. have raised serious concerns over whether or not personalized medicine methods are based on patentable subject matter.

This concern was taken one step further in the recent article Decline of Dosage Regimen Patents in Light of Emerging Next-Generation DNA Sequencing Technology and Possible Strategic Responses, which discussed the potential impact this may have on the pharmaceutical industry. Among the concerns addressed was the impact of not being able to obtain patents on dosing regimens for drugs developed by pharmaceutical companies. While a pharmaceutical company should have no problem patenting a novel medication it has developed, adding additional patent protection to its patent portfolio surrounding that product, such as patents on dosing regimens, has long been a practice utilized to keep competitors at bay. Considering the massive investment in research and development required to bring a new drug to market (sometimes billions of dollars), pharmaceutical companies are rightly alarmed by any potential loss of patent protection they may experience on their product. As the article mentioned, this issue will also surely be compounded by the transition to personalized medicine and integrated healthcare, but it may also be a self-solving problem.

Though the article is concerned with the impact personalized medicine may have on pharmaceutical companies if they no longer can obtain patent protection on dosing regimens, researchers developing personalized medicine methods currently face the same issues. In order for personalized medicine to have an impact on pharmaceutical companies, it must be a fully developed method that has been integrated into everyday healthcare practices. For that to happen, researchers must have a fundamental understanding of what specific genes give rise to differences in patients’ responses to medication. This has proven to be a long and expensive process requiring the systematic sequencing of millions of genes from numerous subpopulations of patients; and all of this work is expensive. Given that the end result of personalized medicine research is a method of administering medication based on an individual’s genetic make-up, patents on personalized medicine fall victim to the same issue facing pharmaceutical companies’ dosing regimen patents.

Lacking the ability to obtain patent protection on personalized medicine methods, the economic feasibility of research in this area becomes more questionable. To circumvent this dilemma, those within the field of personalized medicine will most certainly be looking for the same solutions as pharmaceutical companies. Therefore, one of two results will likely occur, both of which may solve the issues of dosing regimen patentability facing the pharmaceutical companies. One possibility is that the field of personalized medicine will be unable to economically sustain future research without patent protection and fully integrated healthcare will never become a reality; making this issue disappear for pharmaceutical companies. The other, more likely, possibility is that in order for research in the field of personalized medicine to continue, those researchers will solve the very dilemma that pharmaceutical companies fear will be brought about by the emergence of integrated healthcare. Either way, pharmaceutical companies’ dosing regimen patents are so closely tied to the fate of personalized medicine patents that the emergence of integrated healthcare most likely cannot occur in a manner that will be detrimental to pharmaceutical companies’ patent portfolio.

Something to Chew On: The FDA, Food, and a Healthy Dose of Definitions

February 21, 2017
Drug Policy, FDA, Health, Regulatory

MJLST Guest Blogger, Tommy Tobin

[Editor’s Note: This post is #3 in a series on current FDA issues. You can find the previous post here and here.]

Is food medicine? The answer to this simple question is surprisingly complicated.

The name of the Food and Drug Administration (FDA) seems to distinguish between foods and drugs. So too does the Federal Food, Drug, and Cosmetics Act, which helpfully defines “food” as “(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.”

While it is not difficult to swallow the concept of chewing gum being food, the broad legal definition of “food” is somewhat circular and does not provide much guidance by itself. Indeed, the definition of “drug” under the same law notes that drugs are, in relevant part, “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”

Setting the table for further discussion, it should be noted that foods and drugs face different regulatory burdens. For example, drugs face pre-market approval. As for foods, the FDA does not have sole regulatory oversight over food products, which it shares with approximately 14 other federal agencies. The Government Accountability Office labeled the patchwork of federal food safety oversight as a “high risk issue” noting that it had caused “inconsistent oversight, ineffective coordination, and inefficient use of resources.”

Knowing whether an item is a drug or a food dictates whether it is regulated appropriately and even which laws apply to the item. From the definitions, it would seem that foods are categorically not drugs. Yet, sometimes foods do function as medicine. For example, the Harvard Food Law & Policy Clinic argues that “for critically and chronically ill people, food is medicine.” Part of the Clinic’s work has advocated for expanded medically-tailored food and nutrition interventions to improve health outcomes and reduce overall health care costs for high-risk, high-need populations. Even outside of high-risk populations, it is likely many of us provide self-care through food, such as sipping chicken soup for colds or the flu.

Adding more food for thought, there are several terms that blur the lines between the categories of “food” and “drug.” The FDA notes that “terms like ‘functional foods’ or ‘nutraceuticals’ are widely used in the marketplace” but are not explicitly defined in the Food, Drug, and Cosmetic Act. While one could devote a book to the regulation of nutraceuticals and functional foods (and some have done so), it is sufficient here to note that nutraceuticals and functional foods have their own definitions in the relevant, non-regulatory literature. According to an article in the aptly-titled scholarly journal Nutrients, a nutraceutical is “food (or part of a food) that provides medical or health benefits, including the prevention and/or treatment of a disease” and functional foods are “food products that have an added positive health benefit” (internal citations omitted). Notably, each definition expressly notes that these items are foods, not drugs. Put another way, an apple a day may keep doctors away, but apples enriched with antioxidants may be a functional food that merits a price premium from consumers.

The terms have largely arisen out of marketing practice, and a combination of the words “nutrition” and “pharmaceutical.” Entire publications have devoted themselves to the news and scholarly analysis of these products, including Nutraceuticals World and the Journal of Functional Foods. One recent article examined whether Jelly Belly, the jelly bean purveyor, could support its claims that its Sports Beans were “clinically-proven” to maximize sports performance.

Further blurring the line between foods and drugs, a “medical food” is defined under a statute that has “drug” in the name, but the product is not actually a “drug.” A “medical food” is defined under the Orphan Drug Act, as “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” Pursuant to the above definition, the FDA has declared that medical foods must be taken only under the supervision of a physician. According to a recent FDA Guidance Document, medical foods are explicitly not drugs and are not subject to the requirements that apply to drugs. As an example, one medical food, Deplin, is an orange pill that advertises itself as a “prescription medical food” specifically designed to meet the “clinical dietary management of depression and schizophrenia.”

In the supermarket, consumers may stroll from the pharmacy aisles to the food aisles, seeing pharmaceuticals one moment and nutraceuticals the next. With consumers willing to pay a price premium for healthy foods, including functional foods, foods that make claims to reduce disease and promote good health are likely here to stay.

En-Chantix: Smoking Cessation & Involuntary Intoxication

February 13, 2017
Criminal Law, FDA, Health

MJLST Guest Blogger, Tommy Tobin

[Editor’s Note: This post is #2 in a series on current FDA issues. You can find the previous post here.]

Smoking cessation is a difficult process. To assist patients in the process, many physicians are turning to Chantix (Varenicline), which is advertised as the nation’s #1 prescribed prescription anti-smoking medication. Health professionals have lauded the product as a useful adjunct to other methods of smoking cessation treatment and over 10 million Americans have received prescriptions for the drug.

After the introduction of Chantix into the market, reports of adverse events, including potentially serious neuropsychiatric effects, prompted the FDA to issue a black box warning in 2009 for the drug. In 2014, McClatchy reported that Pfizer, Chantix’s manufacturer, had paid at least $299 million to settle civil claims regarding the drug and its alleged neuropsychiatric effects. In December 2016, the FDA approved the removal of this black box warning. While these events certainly are of interest to drug manufacturers and regulators, they also have surprising implications for criminal law.

What if your anti-smoking drug led you to commit a violent crime? Could you convince a jury that the anti-smoking pill made you do it? That is precisely the question posed by some criminal defendants across the country.

Involuntary intoxication can be an affirmative defense for criminal offenses, and this defense is recognized as a complete defense. As a complete defense, the court recognizes that the defendant committed the action alleged but absolves the accused of criminal responsibility due to the circumstances surrounding the commission of the crime. While standards for this defense vary, criminal defendants alleging such a defense generally claim that they were intoxicated and that this intoxication was not the result of their voluntary action. Many courts apply the same standard as in an insanity defense, which asks whether the intoxicated defendant became unable to distinguish right from wrong.

In one high-profile case, an American soldier repeatedly stabbed and brutally murdered another soldier at Fort Benning, Georgia. The defendant in this case, United States v. MacDonald, was taking Chantix and claimed that he should have been afforded an involuntary intoxication instruction at trial. The US Court of Appeals for the Armed Forces ruled that the lower court had a sua sponte duty to instruct on the defense of involuntary intoxication, finding that it was error to fail to provide a separate and distinct involuntary intoxication instruction in such a case. The MacDonald defendant was granted a rehearing, whereupon his sentence was decreased from life without parole to 45 years with credit for time served pursuant to a plea deal. The case went up on appeal on January 27, 2017 and was affirmed.

In another case, a Maryland man invoked Chantix when he was accused of attempting to kill his wife. As reported in the Washington Post, the man shot his wife and tried to get a second shot off but the gun malfunctioned. At trial, he claimed that Chantix caused an internal imbalance of chemicals, resulting in involuntary intoxication. The judge agreed and ordered that he be released. The local paper reported that a small protest followed the Maryland order, with protestors carrying signs that read “Abusers blame victims, Judges blame Chantix.”

When defendants allege a so-called “Chantix defense,” it is far from a sure thing. Providing a court with evidence in addition to conclusory allegations may improve the chances of a favorable finding. For example, a Florida man argued with his father and shortly thereafter killed him. Subsequent to the murder, the man called 911 attempting to blame a non-existent intruder. According to the court, the “Chantix defense” was considered but ultimately rejected by the defense counsel. After trial, the man brought a prisoner litigation action. In rejecting the suit, the court concluded, inter alia, that “even if a reasonable juror could find that Chantix rage exists,” the prisoner had presented no evidence that he was so affected.

As noted in the Washington Post, involuntary intoxication is not a new defense but it is being invoked with increasing success nationwide. While the FDA recently removed Chantix’s black box warning, the “Chantix defense” demonstrates the fascinating interplay between FDA law and criminal law. It remains to be seen just how much the defense bar will incorporate this defense into clients’ strategies.