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Thursday, September 26, 2013

Preemption of Drug and Medical Device Claims: A Legal Overview

Andrew Nolan
Legislative Attorney 

Jennifer A. Staman
Legislative Attorney

The interaction between state tort laws and the federal regulation of medical devices and drugs has been a source of constant litigation in recent years. In the last two decades, the Supreme Court has issued several decisions concerning whether the Federal Food, Drug, and Cosmetic Act (FDCA) preempts state tort law. The results have been mixed: in some cases a person injured by an allegedly defective drug or device is barred from suing a manufacturer, whereas in other cases, the Supreme Court has allowed a lawsuit to proceed. Following these decisions, ambiguities exist concerning the scope of federal preemption in these medical device and drug cases.

With respect to medical devices, state-law tort claims brought against device makers are restricted by a provision of the FDCA that expressly preempts state “requirements” that are “different from, or in addition to” federal requirements applicable to a device and that “relate[] to the safety or effectiveness of the device.” The Supreme Court has generally found that under this provision, the ability of an individual to bring a state-law tort suit alleging certain defects with a medical device can hinge on, among other things, how that device received marketing approval from the Food and Drug Administration (FDA). In Medtronic v. Lohr, the Court found that state-law claims involving “substantially equivalent” medical devices cleared through the § 510(k) process were not barred by the FDCA’s express preemption provision. However, in Riegel v. Medtronic, the Court concluded that if the FDA grants approval to a medical device under its more rigorous premarket approval process, the device manufacturer is immune from certain suits under state tort law. The Court has also found in Buckman v. Plaintiff’s Legal Committee that state-law tort claims stemming from violations of the FDCA may be impliedly preempted by federal law. Despite these three decisions, questions remain about what state-law tort claims survive federal preemption.

In contrast to its provisions on medical devices, the FDCA does not contain an express preemption clause with respect to its prescription drug mandates. Nonetheless, the elaborate premarket approval scheme for drugs created by the FDCA has the potential to clash with state tort law, raising questions as to whether these laws may be preempted. The Court has recently handed down three landmark rulings that clarify when the FDCA’s drug requirements preempt state tort law. In 2009, the Supreme Court, in Wyeth v. Levine, held that a person hurt by a brand name drug could sue the manufacturer under state tort law for a failure to properly warn about the dangers of the drug. However, in a second case, PLIVA v. Mensing, the Supreme Court ruled that a person hurt by a generic drug could not bring the same failure-to-warn claim because changing the labeling of a generic drug would conflict with federal law that requires a generic drug to be the “same” as its branded equivalent in all material respects, including its labeling. Finally, in Mutual Pharmaceutical v. Bartlett, the question for the Court was whether a person harmed by a generic drug could obtain relief on a theory other than a failure-to-warn claim. The Court held that such claims, much like the failure-to-warn claims in Mensing, by imposing heightened duties that would conflict with the “sameness” requirements of federal law regarding generic drugs, were preempted by the FDCA.

This report provides background on the doctrine of preemption and the types of state-law tort claims that have been brought against medical device and prescription drug manufacturers. The report also addresses the federal regulation of medical devices and drugs under the FDCA. With that background in mind, the report discusses the major FDCA preemption cases that have been recently issued by the Supreme Court. Finally, the report covers possible judicial and legislative developments that may affect this dynamic area of law.

Date of Report: September 10, 2013
Number of Pages: 42
Order Number: R43218
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Tuesday, September 24, 2013

Synthetic Drugs: Overview and Issues for Congress

Lisa N. Sacco
Analyst in Illicit Drugs and Crime Policy

Kristin Finklea
Acting Section Research Manager and Specialist in Domestic Security

Synthetic drugs, as opposed to natural drugs, are chemically produced in a laboratory. Their chemical structure can be either identical to or different from naturally occurring drugs, and their effects are designed to mimic or even enhance those of natural drugs. When produced clandestinely, they are not typically controlled pharmaceutical substances intended for legitimate medical use. Designer drugs are a form of synthetic drugs. They contain slightly modified molecular structures of illegal or controlled substances, and they are modified in order to circumvent existing drug laws. While the issue of synthetic drugs and their abuse is not new, Congress has demonstrated a renewed concern with the issue.

From 2009-2011, synthetic drug abuse was reported to have dramatically increased. During this time period, calls to poison control centers for incidents relating to harmful effects of synthetic cannabinoids (such as “K2” and “Spice”) and stimulants (such as “bath salts”) increased at what some considered to be an alarming rate. The number of hospital emergency department visits involving synthetic cannabinoids more than doubled from 2010 to 2011. In 2012, however, the number of calls to poison control centers for incidents relating to harmful effects of synthetic cannabinoids and synthetic stimulants decreased. The Monitoring the Future (MTF) survey results from 2012 indicate that annual prevalence rates for use of “bath salts” among college students and adults ages 18-50 was “very low.” In contrast, MTF reports that, among 12
th graders, synthetic marijuana is the “second most widely used class of illicit drug after marijuana.” Media reports indicate that a synthetic substance known as “molly,” a psychoactive drug that may be similar or identical to MDMA (3,4-Methylenedioxymethamphetamine), appears to be gaining popularity among youth. In the summer of 2013, several deaths and drug overdoses have been attributed to molly.

The reported harmful effects of synthetic substances range from nausea to drug-induced psychosis. Due to the unpredictable nature of synthetic drugs and of human consumption of these drugs, the true effects of many of these drugs are unknown. Many states have responded to the synthetic drug abuse issue by passing synthetic drug laws banning certain synthetic cannabinoids and stimulants.

In 2011, the Attorney General—through the Drug Enforcement Administration (DEA)—used his temporary scheduling authority to place five synthetic cannabinoids and three synthetic stimulants on Schedule I of the Controlled Substances Act (CSA). Concern over the reported increase in use of certain synthetic cannabinoids and stimulants resulted in legislative action to schedule specific substances. The Synthetic Drug Abuse Prevention Act of 2012—Subtitle D of Title XI of the Food and Drug Administration Safety and Innovation Act (P.L. 112-144)—added five structural classes of substances in synthetic cannabinoids (and their analogues) as well as 11 synthetic stimulants and hallucinogens to Schedule I of the CSA. In addition, the act extended the DEA’s authority to temporarily schedule substances. In April 2013, Attorney General Holder— through the DEA and in consultation with the Department of Health and Human Services (HHS)—took administrative action to permanently place methylone on Schedule I of the CSA. Most recently in May 2013, Attorney General Holder—again through the DEA—used his temporary scheduling authority to place three additional synthetic cannabinoids on Schedule I of the CSA.

In considering permanent placement of synthetic substances on Schedule I of the CSA, there are several issues on which Congress may deliberate. Policymakers may consider the implications on the federal criminal justice system of scheduling certain synthetic substances. Another issue up for debate is whether Congress should schedule certain synthetic substances or whether these substances merit Attorney General (in consultation with the Secretary of HHS) scheduling based on qualifications specified in the CSA. Congress may also consider whether placing additional synthetic drugs on Schedule I may hinder future medical research. In addition, policymakers may consider whether it is more efficient to place these drugs on Schedule I of the CSA or to treat them as analogue controlled substances under the Controlled Substances Analogue Enforcement Act. In considering enforcement challenges identified by the DEA, Congress may consider whether to amend the CSA to better facilitate enforcement action against the illicit synthetic drug market.

Date of Report: September 16, 2013
Number of Pages: 22
Order Number: R42066
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The Supplemental Nutrition Assistance Program: Categorical Eligibility

Gene Falk
Specialist in Social Policy

Randy Alison Aussenberg
Analyst in Nutrition Assistance Policy

The Supplemental Nutrition Assistance Program (SNAP) provides benefits to low-income, eligible households on an electronic benefit transfer (EBT) card; benefits can then be exchanged for foods at authorized retailers. SNAP reaches a large share of low-income households. In June 2013, there were 47.7 million persons in 23.1 million households benefitting from SNAP. Federal SNAP law provides two basic pathways for financial eligibility to the program: (1) meeting program-specific federal eligibility requirements; or (2) being automatically or “categorically” eligible for SNAP based on being eligible for or receiving benefits from other specified low-income assistance programs. Categorical eligibility eliminated the requirement that households who already met financial eligibility rules in one specified low-income program go through another financial eligibility determination in SNAP.

In its traditional form, categorical eligibility conveys SNAP eligibility based on household receipt of cash assistance from Supplemental Security Income (SSI), the Temporary Assistance for Needy Families (TANF) block grant, or state-run General Assistance (GA) programs. However, since the 1996 welfare reform law, states have been able to expand categorical eligibility beyond its traditional bounds. That law created TANF to replace the Aid to Families with Dependent Children (AFDC) program, which was a traditional cash assistance program. TANF is a broadpurpose block grant that finances a wide range of social and human services. TANF gives states flexibility in meeting its goals, resulting in a wide variation of benefits and services offered among the states. SNAP allows states to convey categorical eligibility based on receipt of a TANF “benefit,” not just TANF cash welfare. This provides states with the ability to convey categorical eligibility based on a wide range of benefits and services. TANF benefits other than cash assistance typically are available to a broader range of households and at higher levels of income than are TANF cash assistance benefits.

As of October 1, 2012, 43 jurisdictions have implemented what the U.S. Department of Agriculture (USDA) has called “broad-based” categorical eligibility. These jurisdictions generally make all households with incomes below a state-determined income threshold eligible for SNAP. States do this by providing households with a low-cost TANF-funded benefit or service such as a brochure or referral to an “800” number telephone hotline. There are varying income eligibility thresholds within states that convey “broad-based” categorical eligibility, though no state has a gross income limit above 200% of the federal poverty guidelines. In all but five of these jurisdictions, there is no asset test required for SNAP eligibility. Categorically eligible families bypass the regular SNAP asset limits. However, their net incomes (income after deductions for expenses) must still be low enough to qualify for a SNAP benefit. That is, it is possible to be categorically eligible for SNAP but have net income too high to actually receive a benefit. The exception to this is one- or two-person households that would still receive the minimum benefit.

The omnibus “farm bill” approved by the Senate on June 10, 2013 (S. 954), reauthorizes and makes certain changes to SNAP, but does not make changes affecting categorical eligibility. On the other hand, H.R. 3102 (the “Nutrition Reform and Work Opportunity Act of 2013”), which is pending in the House, would restrict SNAP categorical eligibility to only those households receiving need-tested cash assistance (the traditional form of categorical eligibility), ending the state option to have “broad-based” categorical eligibility The Congressional Budget Office (CBO) estimates that an average of 1.2 million persons per year would lose eligibility because of the categorical eligibility restrictions in H.R. 3102 over the next 10 years; it would also result in
budget savings of $11.4 billion over the 5 years from FY2014 to FY2018, and $19.0 billion over the 10 years from FY2014 to FY2023. 

Date of Report: September 17, 2013
Number of Pages: 23
Order Number: R42054
Price: $29.95

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Tuesday, September 3, 2013

Health Workforce Programs in Title VII of the Public Health Service Act

Bernice Reyes-Akinbileje
Analyst in Health Resources and Services

Title VII of the Public Health Service Act (PHSA) supports health professions education and training through grants to and contractual agreements with institutions, and direct assistance to individuals. Institutions may receive Title VII support for such activities as residency programs at medical and dental schools, recruitment and retention initiatives in community-based educational settings, and health workforce data collection and analysis within state health departments. Individuals typically receive direct assistance through scholarships, loans, loan repayments, or fellowships. Title VII authorizes several advisory groups to make recommendations to the Secretary of Health and Human Services and Congress on various health workforce programs and Title VII functions. The Health Resources and Services Administration (HRSA), within the Department of Health and Human Services (HHS), oversees programs authorized in Title VII.

The health care workforce—the backbone of the health care delivery system—includes physicians, nurses, dentists, therapists, and others who deliver health services to individuals in physicians’ offices, health centers, clinics, and other community-based health care settings. In 2010, Congress reauthorized Title VII health workforce programs and activities in the Patient Protection and Affordable Care Act (ACA, P.L. 111-148, as amended). The ACA also added several new authorities that aim to build and sustain the health care workforce alongside other provisions for health reform, including health insurance expansion.

The 113th Congress has held hearings and introduced legislation to address the adequacy of the health care workforce. Health policy experts anticipate that ACA provisions for health insurance expansion could lead to an increased demand for health service utilization, and they expect that this increased demand for services could prompt increased demand for health providers, including physicians and nurses. Other factors causing concern about the adequacy of the health workforce include uneven provider distribution, attrition and retirement, and demands of the aging population. Legislative interest or action may focus on the impact of Title VII programs on education and training in the health professions.

This report describes and summarizes Title VII programs. It describes federal support for institutions and individuals in efforts to expand and sustain the pipeline for health professions education and training. Appendix A summarizes ACA initiatives for health workforce provisions related to Title VII.
related to Title VII.


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