FDA’s Authority to Regulate Drug Compounding: A Legal Analysis

Jennifer Staman
Legislative Attorney

In light of the recent meningitis outbreak, believed to have been caused by a contaminated compounded steroid injection, the regulation of drug compounding has received significant attention. Compounding is traditionally defined as a process of combining, mixing, or altering ingredients in order to create a medication for a particular patient. However, as in the case of the pharmacy that produced the steroid medication, concerns have been raised about compounding pharmacies producing drugs on a larger scale, something more akin to drug manufacturing. While drug compounding has historically been regulated primarily by states through their regulation of pharmacies, recent questions have been raised about the extent to which the Federal Food, Drug, and Cosmetic Act (FFDCA) governs this practice, and what authority the U.S. Food and Drug Administration (FDA) has to regulate a compounded drug as a “new drug,” subject to approval by the FDA, as well as other requirements.

In 1997, Congress enacted the FDA Modernization Act of 1997 (FDAMA), which was a comprehensive revision of the FFDCA. Section 127 of FDAMA added Section 503A to the FFDCA, which excepted compounded drugs from various “new drug” requirements, conditioned upon the compounded drugs meeting a variety of restrictions. One of the restrictions in Section 503A of the FFDCA was that drug providers were prohibited from soliciting or advertising particular compounded drugs. These speech restrictions were challenged on First Amendment grounds and were struck down by the Supreme Court in Thompson v. Western States Medical Center. Following this decision, there was controversy over the current status of compounded drugs under the FFDCA and whether the remaining provisions of Section 503A remain good law, an issue that the Supreme Court did not address in Western States. The two circuits that addressed this issue took different positions. While the Ninth Circuit in Western States determined that Section 503A was struck down in its entirety, the Fifth Circuit in Medical Center Pharmacy v. Mukasey found that the lawful provisions of Section 503A are still in effect. Accordingly, these cases have created an interesting scenario of non-uniform enforcement throughout the U.S. In the Fifth Circuit, compounded drugs are specifically exempted from new-drug, adulteration, and misbranding requirements of the FFDCA if certain criteria are met; while in the Ninth Circuit (and, according to the FDA, the rest of the United States), compounded drugs are subject to these requirements, but the FDA may exercise discretion in taking action against an entity that violates these provisions. This report provides a brief historical overview of the FDA’s regulation of drug compounding and addresses these conflicting decisions. The report will also address the FDA’s current authority to regulate compounded drugs under the FFDCA in light of these decisions.


Date of Report: October 17, 2012
Number of Pages: 14
Order Number: R40503
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The President’s Emergency Plan for AIDS Relief (PEPFAR): Funding Issues After a Decade of Implementation, FY2004-FY2013

Tiaji Salaam-Blyther
Specialist in Global Health

The President’s Emergency Plan for AIDS Relief (PEPFAR) is the largest bilateral health initiative in the world. The 2003 pledge of President George W. Bush to spend $15 billion over five years on fighting HIV/AIDS, tuberculosis (TB), and malaria was considered groundbreaking. The initiative challenged the international community to reject claims that large-scale HIV/AIDS treatment plans could not be carried out in low-resource settings. In December 2002, one month before PEPFAR was announced, only 50,000 people of the estimated 4 million requiring antiretroviral (ARV) medicines in sub-Saharan Africa were receiving treatment. By the end of FY2004, 155,000 people were receiving treatment through PEPFAR.

As of March 2012, PEPFAR has supported

• the provision of anti-retroviral therapy (ART) for more than 4.5 million people (up from 155,000 in 2005);
• testing and counseling for more than 40 million people, including 9.8 million pregnant women;
• prevention of mother-to-child HIV transmission (PMTCT) services for more than 660,000 HIV-positive pregnant women, curbing some 200,000 HIV infections among infants; and
• care and support for more than 13 million people, including more than 4 million orphans and vulnerable children (OVC).

Congress first authorized funds in support of PEPFAR in 2003 through P.L. 108-25, the U.S. Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act (Leadership Act). The $15 billion authorization was to be spent on global HIV/AIDS, TB, and malaria programs from FY2004 through FY2008. Strong bipartisan support for PEPFAR in particular and global health in general led to annual appropriations amounts that exceeded authorized levels. During the first phase of PEPFAR (FY2004-FY2008), the Bush Administration spent $18.1 billion on global HIV/AIDS programs.

As the expiration date of the Leadership Act approached, congressional support for PEPFAR remained enthusiastic. Members debated a range of issues (see CRS Report RL34569, PEPFAR Reauthorization: Key Policy Debates and Changes to U.S. International HIV/AIDS, Tuberculosis, and Malaria Programs and Funding), but ultimately authorized an extension of PEPFAR. The Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008 (P.L. 110-293, Lantos-Hyde Act) authorized $48 billion to be appropriated from FY2009 through FY2013 for combating the three diseases. From FY2009 through FY2012, the Obama Administration obligated nearly $26 billion on global HIV/AIDS programs.

As the September 30, 2013, expiration date for the authorization of the Lantos-Hyde Act approaches, it is unclear whether Congress will again authorize multiyear funding for PEPFAR. Bipartisan support for PEPFAR remains strong; nonetheless, congressional debate about key elements of the program has raised some concerns. For example, some Members question the extent to which family planning programs are integrated into global HIV/AIDS activities. At the same time, growing unease about the federal budget deficit minimizes the likelihood that past trends of ever-increasing appropriations for global HIV/AIDS programs will be sustained.


Date of Report: October 10, 2012
Number of Pages: 17
Order Number: R42776
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Health Insurance Exchanges Under the Patient Protection and Affordable Care Act (ACA)

Bernadette Fernandez
Specialist in Health Care Financing

Annie L. Mach
Analyst in Health Care Financing

The fundamental purpose of a health insurance exchange is to provide a structured marketplace for the sale and purchase of health insurance. The authority and responsibilities of an exchange may vary, depending on statutory or other requirements for its establishment and structure. The Patient Protection and Affordable Care Act (ACA, P.L. 111-148, as amended) requires health insurance exchanges to be established in every state by January 1, 2014. ACA provides certain requirements for the establishment of exchanges, while leaving other choices to be made by the states.

Qualified individuals and small businesses will be able to purchase private health insurance through exchanges. Issuers selling health insurance plans through an exchange will have to follow certain rules, such as meeting the private market reform requirements in ACA. While the fundamental purpose of the exchanges will be to facilitate the offer and purchase of health insurance, nothing in the law prohibits qualified individuals, qualified employers, and insurance carriers from participating in the health insurance market outside of exchanges. Moreover, ACA explicitly states that enrollment in exchanges is voluntary and no individual may be compelled to enroll in exchange coverage.

Exchanges may be established either by the state itself as a “state exchange” or by the Secretary of Health and Human Services (HHS) as a “federally facilitated exchange.” All exchanges are required to carry out many of the same functions and adhere to many of the same standards, although there are important differences between the types of exchanges. States will need to declare their intentions to establish their own exchanges by no later than November 16, 2012.

ACA and regulations require exchanges to carry out a number of different functions. The primary functions relate to determining eligibility and enrolling individuals in appropriate plans, plan management, consumer assistance and accountability, and financial management. ACA gives various federal agencies, primarily HHS, responsibilities relating to the general operation of exchanges. Federal agencies are generally responsible for promulgating regulations, creating criteria and systems, and awarding grants to states to help them create and implement exchanges.

A state that is approved to operate its own exchange has a number of operational decisions to make, including decisions related to organizational structure (governmental agency or a nonprofit entity); types of exchanges (separate individual and Small Business Health Options Program (SHOP) exchanges, or a merged exchange); collaboration (a state may independently operate an exchange or enter into contracts with other states); service area (a state may establish one or more subsidiary exchanges in the state if each exchange serves a geographically distinct area and meets certain size requirements); contracted services (an exchange may contract with certain entities to carry out one or more responsibilities of the exchange); and governance (governing board and standards of conduct).

In general, health plans offered through exchanges will provide comprehensive coverage and meet all applicable private market reforms specified in ACA. Most exchange plans will provide coverage for “essential health benefits,” at minimum; be subject to certain limits on cost-sharing, including out-of-pocket costs; and meet one of four levels of plan generosity based on actuarial value. To make exchange coverage more affordable, certain individuals will receive premium assistance in the form of federal tax credits. Moreover, some recipients of premium credits may also receive subsidies toward cost-sharing expenses.


Date of Report: October 10, 2012
Number of Pages: 38
Order Number: R42663
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Budget Control Act: Potential Impact of Sequestration on Health Reform Spending

C. Stephen Redhead
Specialist in Health Policy

The Budget Control Act of 2011 (BCA; P.L. 112-25) established new budget enforcement mechanisms for reducing the federal deficit by at least $2.1 trillion over the 10-year period FY2012-FY2021. The BCA placed statutory limits, or caps, on discretionary spending for each of those 10 fiscal years, which will save an estimated $0.9 trillion during that period. In addition, it created a Joint Select Committee on Deficit Reduction (Joint Committee) with instructions to develop legislation to reduce the federal deficit by at least another $1.5 trillion through FY2021. On November 21, 2011, the Joint Committee announced that it was unable to agree on a legislative package of deficit cuts, which raises the likelihood of automatic annual spending reductions beginning in FY2013. Under the BCA, the reductions would be achieved by a combination of sequestration—an automatic across-the-board cancellation of budgetary resources (i.e., spending cuts) for nonexempt direct spending programs—and lowering the caps on discretionary spending.

The potential impact of spending reductions triggered by the BCA on health reform spending under the Patient Protection and Affordable Care Act (ACA) would appear to be somewhat limited. ACA sought to increase access to affordable health insurance by expanding the Medicaid program and by restructuring the private health insurance market. It set minimum standards for private insurance coverage, created a mandate for most U.S. residents to obtain coverage, and provided for the establishment by 2014 of state-based insurance exchanges for the purchase of health insurance. Certain individuals and families will be able to receive federal subsidies to reduce the cost of purchasing coverage through the exchanges. The new law included direct spending to subsidize the purchase of health insurance coverage through the exchanges, as well as increased outlays for the Medicaid expansion. Under the rules governing sequestration, Medicaid spending would be exempt from any reduction, and cuts to Medicare would be capped at 2%.

ACA also included numerous mandatory appropriations that provide billions of dollars to support temporary programs to increase coverage and funding for targeted groups, provide funds to states to plan and establish exchanges, and support many other research and demonstration programs and activities. These appropriations would, in general, be subject to direct spending reductions under a sequestration order. However, for any given fiscal year in which sequestration was ordered, only new budget authority for that year (including advance appropriations that first become available for obligation in that year) would be reduced. Unobligated balances carried over from previous fiscal years would be exempt from sequestration.

ACA is likely to affect discretionary spending subject to the annual appropriations process. The law reauthorized appropriations for numerous existing discretionary grant programs and activities authorized under the Public Health Service Act, permanently reauthorized funding for the Indian Health Service (IHS), and created a number of new grant programs and provided for each an authorization of appropriations. In addition, the Congressional Budget Office projected that both the Department of Health and Human Services and the Internal Revenue Service will incur substantial administrative costs to implement the policies and programs established by ACA. Those costs will have to be funded largely through the annual appropriations process. ACArelated discretionary spending would, in general, be subject to automatic spending reductions triggered by the BCA.


Date of Report: October 1, 2012
Number of Pages: 23
Order Number: R42051
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Medicare Payment Updates and Payment Rates

Paulette C. Morgan, Coordinator
Specialist in Health Care Financing

Cliff Binder
Analyst in Health Care Financing

Patricia A. Davis
Specialist in Health Care Financing

Barbara English
Information Research Specialist

Jim Hahn
Specialist in Health Care Financing

Scott R. Talaga
Analyst in Health Care Financing

Sibyl Tilson
Specialist in Health Care Financing

Medicare is a federal insurance program that pays for covered health services for most persons 65 years of age and older and for most permanently disabled individuals under the age of 65. Part A of the program, the Hospital Insurance program, covers hospital, post-hospital, and hospice services. Part B, the Supplementary Medical Insurance program, is optional and covers a broad range of complementary medical services including physician, laboratory, outpatient hospital services, and durable medical equipment. Part C provides private plan options for beneficiaries enrolled in both Parts A and B. Part D is an optional outpatient prescription drug program.

Medicare has established specific rules for payment of covered benefits. Some, such as physician services and most durable medical equipment, are based on fee schedules. A fee schedule is a list of Medicare payments for specific items and services, which are calculated according to statutorily specified formula and take into account the actual amount of care provided. Many services, including inpatient and outpatient hospital care, are paid under different prospective payment systems (PPSs). A prospective payment system is a method of paying hospitals or other providers amounts or rates of payment that are established in advance for a defined period and are generally based on an episode of care, regardless of the actual amount of care used. Other payments are based, in part, on a provider’s bid (an estimate of the cost of providing a service) relative to a benchmark (the maximum amount Medicare will pay). Bids and benchmarks are used to determine payments in Medicare Parts C and D. Payments for some items of durable medical equipment in specified locations are also based on the bids of competing providers.

In general, the program provides for annual updates to these payment amounts. The program also has rules regarding the amount of cost sharing, if any, that beneficiaries can be billed in excess of Medicare’s recognized payment levels. Unlike other services, Medicare’s outpatient prescription drug benefit can be obtained only through private plans. Further, while all Part D plans must meet certain minimum requirements, they differ in terms of benefit design, formulary drugs, premiums, and cost-sharing amounts.

Medicare payment policies and potential changes to these policies are of continuing interest to Congress. The Medicare program has been a major focus of deficit reduction legislation since 1980. In each Congress since the 105th Congress, laws have been passed to both increase, but more often slow, the rate of growth of payments to Medicare providers and private plans. Perhaps of particular interest in the 112th Congress is the update to the Medicare physician fee schedule. The method for updating the physician fee schedule amount, known as the sustainable growth rate (SGR), would have resulted in negative updates for physician payments in recent years, except that Congress has stepped in to stop the updates. Physician payment rates are frozen through December 31, 2012, after which point, rates will decrease by approximately 27% in the absence of further congressional action.

This report provides an overview of Medicare payment rules by type of service, outlines current payment policies, and summarizes the basic rules for payment updates. This report will be updated twice a year to reflect recent fiscal year and calendar year changes.


Date of Report: September 27, 2012
Number of Pages: 60
Order Number: RL30526
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