Author: Shruti Modi

On March 31, the Health Law and Justice Society hosted its spring symposium “Drug Promotion in the 21^st Century: Off-Label Marketing and First Amendment Concerns.”

Although the Food and Drug Administration (FDA) approves drugs for specific medical purposes, many treatments approved for one use are also effective for other diseases and conditions. The FDA has traditionally prohibited the promotion of medical products for uses other than those approved by the agency and reflected in the labeling. This restriction, however, has recently been weakened by successful legal challenges based on the First Amendment guarantee of freedom of speech. The symposium provided an overview of these issues and assessed recent legal developments, including several important cases decided in the past year. The panelists also discussed the implications of expanding the right to off-label promotion for the FDA, the drug industry, and medical practice. Professor Lewis Grossman, Professor of Law at American University Washington College of Law and food and drug law scholar, introduced and moderated the panel.

 

The speakers for the symposium were 1) Allison Zieve, J.D., Director, Public Citizen Litigation Group; 2) Richard Samp, J.D., Chief Counsel, Washington Legal Foundation; 3) Adriane Fugh-Berman, M.D., Associate Professor and Director of PharmedOut, Georgetown University Medical Center; and 4) Anne K. Walsh, J.D., Director, Hyman, Phelps & McNamara, P.C.

 

Ms. Zieve offered an illustrative history of how FDA’s authority over drugs has evolved. Her comments focused on the FDA’s requirements of safety and efficacy for new drugs before approval for sale on the market and balancing that with what is considered “truthful” speech. She emphasized that laypeople may not be able to properly evaluate truthful scientific statements in terms of safety and efficacy for human use. Furthermore, she stated that allowing industry to successfully use the First Amendment to discuss truthful statements about off-label uses of drugs could potentially have severe consequences for the public.

Mr. Samp’s comments focused on truthful speech, and regulations of commercial speech. He emphasized that the current trend in courts is to apply closer First Amendment scrutiny to restrictions on non-misleading commercial speech.

Ms. Fugh-Berman brought a physician’s and academic perspective on this issue. Among many things, she discussed the fact that while off-label uses of drugs can sometimes be rational and inevitable, most of the time, it is not. She focused on scientific support for off-label uses of drugs. She said that industry controls what information and studies the public sees and that companies usually have a great deal of information regarding off-label uses of their drugs.

Finally, Ms. Walsh’s comments discussed the interplay between the Federal Food, Drug, and Cosmetic Act, and the False Claims Act.

The symposium was an incredible event with truly esteemed speakers. The AUWCL community was incredibly lucky to have such knowledgeable speakers come and offer their expertise. To watch the event and hear further details, please visit: http://media.wcl.american.edu/Mediasite/Play/5a8de06dc577415b84aee30771df3e111d.

On March 15, 2016, the Centers for Disease Control and Prevention (CDC) issued guidelines on prescribing opioid painkillers that were aimed at primary care physicians. These guidelines were a response to the opioid epidemic that has resulted in opioid abuse, overdose, and death. Primary care physicians prescribe nearly half of the opioid painkillers consumed in the United States. These guidelines are not intended for physicians treating cancer patients or for end-of-life care. These guidelines come after several other attempts in recent years to curb the epidemic. In 2014, the Drug Enforcement Agency re-classified some controlled substances from Schedule 3 to the more restrictive Schedule 2. The Obama administration also stepped up general spending on treatment and prevention programs in response.

At the center of the guidelines is the recommendation that non-opioid therapy be the first line of treatment for chronic pain and that opioids only be prescribed when their benefits for pain and function outweigh the risks.

These guidelines have sparked a fierce debate. Some pain specialists and patient advocates have remarked that these guidelines could deny patients pain relief. The line between drug-addicted patients who do not truly need relief and legitimate patients is blurry and difficult to identify.

As the number of deaths from opioids has increased, state and federal agencies have implemented a variety of solutions in attempts to curb these deaths. Some states, like Nebraska, have mandated limits of opioid medications that patients may be prescribed per year. Other states have instituted “pain management contracts,” where patients must agree to random drug testing before receiving an opioid prescription. And many medical associations now offer doctors training in opioids and chronic pain, encouraging them to first try alternative remedies like physical therapy, acupuncture, anti-inflammatories, antidepressants, and counseling. While these other options can work, they don’t always work for some patients who legitimately have an immense amount of pain. These other options can also be much costlier than opioid medications, and not all insurance programs cover all of these remedies.

Critics of the CDC guidelines have argued that the guidelines are not based in strong evidence. However, Dr. Debra Houry, director of the CDC’s National Center for Injury Prevention and Control, counters that evidence for the benefits of opioid medications is also lacking.

While the guidelines are not perfect, they play an important role in the debate around opioid therapy, and finding the line between drug-addicted patients and legitimate ones who need relief.

In April 2015, the Kansas State Legislature passed the Kansas Unborn Child Protection from Dismemberment Abortion Act. This law, with few exceptions, would ban “dilation and evacuation” abortions, or “D&E” abortions. These abortions are the primary method for second-trimester abortions in the United States. These abortions are common and considered the safest option for a second-trimester abortion. Kansas became the first state to ban this procedure.

Weeks before the law was to take effect last summer, three doctors filed a lawsuit over the bill. The key issue was whether the Kansas Constitution provides a right to abortion. In January 2016, an evenly divided Court of Appeals blocked this law, stating that the rights of due process and equal protection protect the procedure. The court, citing Roe v. Wade, further stated that the United States Constitution has protected the right to an abortion for over 40 years. The court affirmed the lower court’s injunction. The case is now going to be reviewed by the Kansas Supreme Court.

The appellate court’s opinion offers both sides of the issue. It states that the “rights of Kansas women are not limited to those specifically intended by the men who drafter our state’s constitution in 1859.” The other side states, “there is nothing within the text or history…the Kansas Constitution Bill of Rights to lead this court to conclude that these provisions were intended to guarantee a right to abortion.”

Opponents of the bill point to the fact that medical science supports this procedure as the safest option, and that to override science is “astonishing.” Furthermore, if this law were to move forward, there would be no alternative for women who seek this procedure.

Supporters of the bill focus on the graphic nature of its title. They argue that proponents of the procedure purposely use terminology that the public can’t understand. In explaining this, they analogize it to a doctor who wouldn’t say, “we’re going to disarticulate your limb. He’s going to say, we’re going to have to break this bone and reset it.”

This case will be widely watched for the effect that it will have on women throughout Kansas, and potentially in other states. This law would place an undue burden on women seeking to exercise their right to this procedure, which the United States Supreme Court also stated was unconstitutional in Stenberg v. Carhart. The Kansas Court of Appeals appropriately protected cited the rights to due process and equal protection for the women in Kansas.

On November 19, the Health Law and Policy Brief hosted its fall symposium “Telemedicine: Regulatory Framework & Barriers to Expansion.” Telemedicine emerged over 40 years ago and is a rapidly expanding area of healthcare in the United States. The panelists at the symposium discussed the current state of Telemedicine, its regulatory framework, and the barriers to its expansion. Mr. Gary Capistrant, the Chief Policy Advisor to the Telemedicine Association, moderated the panels.

The first panel focused on barriers to the expansion of telemedicine. The speakers on the panel were 1) Ms. Alexis Gilroy, Partner at Jones Day; 2) Ms. Amy F. Lerman, Senior Counsel at Epstein Becker Green; and 3) Mr. Jeffrey Mitchell, Of Counsel at Lukas Nace Gutierrez & Sachs LLP.

These three speakers brought up and discussed several important barriers that need to be addressed for telemedicine to reach its full potential. Ms. Alexis Gilroy emphasized that regulation of telemedicine is state by state. Regulators are dealing with a huge number of rules that vary, and there is yet another layer of regulation once telemedicine moves outside of the United States. In some ways, regulators can supervise telemedicine more directly, but varying rules complicate that. A potential solution is to create a federal system of regulation, but that would take away power from states, which raises another host of issues. Ms. Amy Lerman focused on barriers regarding payment. The question from all telemedicine clients is how they are going to get paid. The various state regulatory regimes also have varying reimbursement schemes, which seriously hinder telemedicine, which cannot move forward if they are not paid. Finally, Mr. Jeffrey Mitchell questioned the idea of “universal service.” While technology has made magnificent advances in the last two decades, there is still the problem of affordable access to phones and the Internet in rural areas, which are usually in greater need of telemedicine. Even if rural areas do have access to phones and the Internet, connectivity is constantly an issue. A solution is to subsidize rural phones by overcharging urban businesses, however that comes with its own problems that have yet to be adequately addressed.

The second panel focused on how the federal government regulates mHealth devices. The speakers on this panel were 1) Mr. Daniel Gottlieb, Associate at Epstein Becker Green; and 2) Mr. Robert Jarrin, Senior Director of Government Affairs at Qualcomm.

Both of these speakers built upon the comments of the speakers on the first panel and further elucidated how involved the government is in regulating telemedicine. Mr. Daniel Gottlieb described the various ways that the federal government regulates mHealth devices. Mr. Gottlieb began by applauding telemedicine saying that clinical data obtained through its programs has immense potential to spur medical advances. He explained that clinical and IT personnel collaborate in telemedicine programs. The Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), and the Federal Communications Commission (FCC) then regulate their efforts. If certain programs work with patients in the European Union (EU), they then also must comply with the EU Data Privacy Directive. His points echoed those of Ms. Gilroy. While careful regulation is necessary for safety purposes, Mr. Gottlieb emphasized a need to streamline the regulation of telemedicine. Mr. Jarrin’s points reiterated the fact that there are several regulatory bodies involved in telemedicine. As the Senior Director of Government Affairs for Qualcomm, Mr. Jarrin emphasized that he is responsible for 1) state and federal laws pertaining to telemedicine; 2) FDA regulatory oversight over mHealth devices; 3) congressional committees’ perspectives; 4) Medicare and Medicaid telehealth reimbursement; and 5) FCC broadband healthcare efforts. Compounding these responsibilities is how much of a risk a device is. The FDA classifies devices in different groups based on risk; however determining risk is a complicated process. Mr. Jarrin called for more guidance and transparency from government agencies, particularly the FDA.

The symposium was a wonderful event, and the AUWCL community was incredibly lucky to have such knowledgeable speakers come and offer their expertise.

 

On Monday, March 30, GNC reached an agreement with the New York Attorney General requiring testing standards for their “Herbal Plus” supplements that exceed current Food and Drug Administration (FDA) requirements. This agreement comes almost two months after the NY Attorney General sent letters to GNC, Walmart, Walgreens, and Target for allegedly selling store brand herbal supplements with ingredients that could not be verified or ingredients that were not listed on the labels.

GNC has been fighting lawsuits that have resulted from the New York Attorney General’s announcement because the company believes the lawsuits to be “without merit.” Despite this, GNC reached the agreement with the New York Attorney General to give its consumers “even greater confidence” in its products.

Under the agreement, GNC will perform DNA barcode testing on all “active” plant ingredients listed on labels, and will test for contamination with allergens before and after production. GNC will also make these tests standard procedure before placing their products on any of their stores nationwide. Furthermore, the company will introduce new policies over the next 18 months and submit semi-annual safety reports to the New York Attorney General’s office. The agreement confirms that GNC’s products are in full compliance the FDA’s Current Good Manufacturing Practices. Finally, the agreement recognizes GNC’s full cooperation with the attorney general. As a result of its updated testing, GNC has restored its “Herbal Plus” products to its shelves.

This move is a major shift in the lightly-regulated market for herbal supplements. The herbal supplement industry is estimated to be worth $60 billion worldwide. However, herbal supplements are not subject to the same level of scrutiny as drugs are by the FDA.

The New York Attorney General’s actions have not only caused GNC to pay attention, but have caused other Attorney Generals to take note as well. In fact, on April 2, a group of 14 state Attorneys General asked the U.S. Congress to investigate the herbal supplements industry. The Attorneys General sent their letter to Kansas Senator Jerry Moran and Pennsylvania Representative Joe Pitts, chairmen of subcommittees on product safety and health. The Attorneys General asked the subcommittees to work with the FDA to determine whether the agency should develop enhanced quality assurance programs and other safety requirements. The attorneys general stated “we believe the safety and efficacy of these supplements is a matter of deep public concern across the country,” and they urged “swift action.”

While industry officials and others say the industry is already sufficiently regulated on a federal level, it is time to re-think federal regulation of herbal supplements. Consumers have a right to know what they are purchasing and putting in their bodies. Most importantly, consumers deserve to know that the claims on these products are validated and that these products are safe.

On January 20, 2015, in his State of the Union Address, President Obama launched a new Precision Medicine Initiative. This research initiative is a bold new effort to improve how we treat disease and how we cure diseases like cancer and diabetes. The Precision Medicine Initiative will pioneer a new model of patient-powered research that aims to accelerate biomedical discoveries and provide clinicians with new tools, knowledge, and therapies to select which treatments will work best for which patients. Personalized medicine is often described as providing “the right patient with the right drug at the right dose at the right time.”

Currently, medical practitioners follow a trial-and-error approach when treating patients. In other words, if a patient has a disease, his or her doctor will prescribe a treatment plan based on general information, and re-assess after a few weeks. If the treatment is not working, the doctor will change some variable in the plan, and wait a few more weeks to see if there is any improvement. This approach can lead to patient dissatisfaction, adverse drug responses and interactions, and poor adherence to treatment regimens by the patient. While this may seem bleak, there have been rapid developments in a variety of medical fields like genomics, medical imaging, and computational biology that are making it possible for scientists and doctors to personalize diagnosis and treatment of diseases. Precision medicine gives clinicians tools to better understand the complex mechanisms underlying a patient’s health, disease, or condition, and to better predict which treatments will be most effective. I believe the Precision Medicine Initiative is just what is needed to continue encouraging creative approaches to precision medicine and build the evidence base necessary to guide clinical practices.

The main objectives of this initiative are:

• An increase in better cancer treatments: The National Cancer Institute (NCI) will accelerate the design and testing of effective, tailored treatments for cancer by expanding genetically based clinical cancer trials, exploring fundamental aspects of cancer biology, and establishing a national “cancer knowledge network,” that will generate and share new knowledge to fuel scientific discovery and guide treatment decisions.
• Creation of a voluntary national research cohort: The National Institute of Health (NIH), in collaboration with other agencies and stakeholders, will launch a national, patient-powered research cohort of one million or more Americans who volunteer to participate in research. Participants will be involved in the design of the initiative and will have the opportunity to contribute diverse sources of data – including (but not limited to) medical records, profiles of patient genes, chemical makeup, and environmental and lifestyle data.
• Commitment to protecting privacy: The White House will launch a multi-stakeholder process with Health and Human Services (HHS) and other Federal agencies to solicit input from patient groups, bioethicists, privacy and civil liberties advocates, technologists, and other experts to identify and address any legal and technical issues related to the privacy and security of patient data.
• Regulatory modernization: The Initiative will review the current regulatory landscape and work with the Food and Drug Administration (FDA) to determine whether changes are needed to support the development of this new research and care model.
• Public-private partnerships: The Obama Administration will forge strong partnerships with existing research cohorts, patient groups, and the private sector to develop the infrastructure that will be needed to expand cancer genomics, and to launch a voluntary million-person cohort.

Key Investments to Launch the Precision Medicine Initiative:

1. $130 million to NIH
2. $70 million to NCI
3. $10 million to FDA
4. $5 million to The Office of the National Coordinator for Health Information Technology (ONC)

In sum, the Precision Medicine Initiative is a great endeavor and its greatest benefits will likely be seen many years in the future. However, this initiative will revolutionize the practice of medicine, and give patients a better chance at good health than they have ever had.