Congress wraps up and finishes by funding the federal government
Congress has adjourned for the year and will reconvene in Washington, D.C. on Jan. 6 to begin the 114th Congress. Any legislation not enacted during this Congress will need to be reintroduced.
One of the last major pieces of legislation to be enacted was legislation to fund operations of the federal government. H.R. 83, a $1.1 trillion spending package spanning 1,600 pages, was signed into law Dec. 16. The bill was referred to as the “crominbus” – a hybrid continuing resolution through February 27 for the Department of Homeland Security, plus funding for 11 of the 12 regular appropriations bills for the rest of the fiscal year.
Contained within the “cromnibus” was $2.59 billion for the Food and Drug Administration (FDA) through the end of the current fiscal year. The legislation provided an overall funding increase of $37 million for the agency, $15 million of which will be used for pharmacy compounding, and $4.82 million for counterfeit drugs. Notably, the bill withholds $20 million from FDA salaries and expenses pending the finalization of guidance on abuse-deterrent opioids’ evaluation and labeling. If guidance is not finalized by June 30, the bill directs the $20 million to be transferred to the agency Office of Criminal Investigation to assist in combating diversion of controlled substances.
Congressional hearing regarding generic drug price increases
On Nov. 20, the Senate Health, Education, Labor and Pensions Subcommittee on Primary Health and Aging held a hearing titled “Why Are Some Generic Drugs Skyrocketing In Price?” The hearing followed an Oct. 2 inquiry launched by Primary Health and Aging Subcommittee Chairman Bernie Sanders (I-VT) and Representative Elijah Cummings (D-MD), Ranking Member of the House Oversight and Government Reform Committee. Senator Sanders and Representative Cummings earlier sent letters to 14 generic drug manufacturers, requesting information about the increasing price of generic drugs.
Pennsylvania pharmacist Rob Frankil testified on behalf of the National Community Pharmacists Association (NCPA), reporting that the generic drug cost spikes hurt both patients and pharmacy owners. Pharmacy owners frequently bear the cost of the price spikes when PBMs do not quickly update their reimbursement rates and continue to pay pharmacies at the lower rates and without reimbursing pharmacies retroactively. Earlier in 2014, the Centers for Medicare and Medicaid Services (CMS) finalized a regulation to require PBMs to update generic price benchmarks every seven days. The regulation will be effective in 2016.
Senator Richard Burr (R-NC) suggested that regulator fees and requirements were one of the factors behind the price increases, noting that there were more generic drug applications pending review than before the generic drug user fee regime was put into place, and the median time for FDA approval of generic drugs had increased from 31 to 36 months.
Senator Elizabeth Warren (D-MA) offered data at the hearing to show that the FDA was not imposing a significant regulatory burden on generic drug makers. She noted that while the FDA had increased the number of warning letters sent to industry from approximately 2,000 in 2011 to nearly 7,000 in 2013, only 11 of those letters involved generic manufacturers while the majority related to tobacco issues.
Representative Cummings, who uses an albuterol inhaler, testified that “some companies are exploiting monopolies and disruptions in supply to implement massive price increases in order to reap unconscionable profits.” He went to say that he would “fight this issue until I die because there are people dying because of it.”
Senate report addresses ways to increase use of generic drugs, requests study of generic price increases
On Dec. 15, the Senate Special Aging Committee released a bipartisan report on ways to increase utilization of generic drugs within the Medicare Part D program. The report called on the Government Accountability Office (GAO) to study and report to Congress regarding the recent price spikes in certain generic drugs.
The Senate report, which followed a two-year review of the issue, recommends incentivizing Part D sponsors who increase use of generics; finding creative ways to encourage generic drug use among low income beneficiaries; increasing beneficiary and health professional education regarding the safety, effectiveness, and cost benefits of generic drugs; and enhancing investigations into pharmacy billing practices that hamper the increase in use of generic drugs.
The report also recommended expansion of medication therapy management (MTM) services, noting that “Given MTM’s potential to improve outcomes and lower costs, it is important that it reaches the full range of beneficiaries who would benefit…” The Committee report suggested that MTM coverage be expanded to include beneficiaries on lower cost generic drugs.
Update on implementation of Drug Quality and Security Act (DQSA)
Pharmacy Compounding Advisory Committee
On Dec. 16, the FDA announced the membership of the Pharmacy Compounding Advisory Committee established by the DQSA. According to the FDA, the 14 members “will provide advice on scientific, technical and medical issues concerning drug compounding.”
- Chairperson - Jurgen Venitz, MD, PhD, Associate Professor, Virginia Commonwealth University School of Pharmacy, Department of Pharmaceutics
- Ned S. Braunstein, MD, Vice President and Head of Regulatory Affairs, Regeneron Pharmaceuticals, Inc.
- Michael A. Carome, MD, FACP, Director, Health Research Group Public Citizen
- Gigi S. Davidson, BSPh, DICVP, Director, Clinical Pharmacy Services North Carolina State University College of Veterinarian Medicine
- Robert DeChristoforo, MS, FASHP, Chief, Clinical Center Pharmacy Department, National Institutes of Health
- John J. DiGiovanna, MD, Staff Clinician DNA Repair Section, Dermatology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health
- Padma Gulur, MD, Professor University of California, Irvine Department of Anesthesiology and Perioperative Care
- Stephen W. Hoag, PhD, Professor University of Maryland, Baltimore Department of Pharmaceutical Science
- William A. Humphrey, BSPharm, MBA, MS Director, Pharmacy Operations St. Jude Children’s Research Hospital
- Elizabeth Jungman, JD, Director of Drug Safety and Innovation, The Pew Charitable Trusts
- William Mixon, RPh, MS, FIACP, Owner-Manager The Compounding Pharmacy
- Katherine Pham, PharmD, BCPS Neonatal Intensive Care Unit Pharmacy Specialist Children’s National Medical Center
- Allen J. Vaida, BSc, PharmD, FASHP, Executive Vice President Institute for Safe Medication Practices
- Donna Wall, PharmD, Clinical Pharmacist Indiana University Hospital
The International Academy of Compounding Pharmacists (IACP) praised the announcement of members but raised serious concern that the Advisory Committee lacked sufficient representation of practicing compounding pharmacists.
Distributors seek extra time to meet tracing requirements
On Dec. 15, the Healthcare Distribution Management Association (HDMA) sent a letter to FDA Commissioner Hamburg requesting at least three extra months to comply with the DQSA drug tracing data requirements, as some distributors would not be ready by Jan. 1. HDMA notes that most primary distributors will be ready by the implementation date, but some distributors may experience challenges beyond their control, potentially resulting in disruptions of supply without enforcement relief.
Compounders ask congress to stop FDA policy on office-use compounding
On Dec. 10, pharmacy and provider organizations, including the IACP, the Professional Compounding Centers of America, the American Medical Association, and the American Pharmacists Association, sent a letter to congressional health care committees of jurisdiction over the FDA, urging Congress to stop FDA from pursuing its policy on office-use compounding. Specifically, the groups assert that the FDA’s approach, requiring patient-specific prescriptions for office-use compounding, is not what Congress intended and threatens patient access to critical antibiotics. The letter cites multiple references in the Congressional Record during debate over and following passage of DQSA demonstrating clear intent that compounded prescriptions for office use remain available.
This Dec. 10 provider and pharmacist organization letter follows an earlier letter to FDA from the Biotechnology Industry Organization, the Generic Pharmaceutical Association, the Pharmaceutical Research and Manufacturers of America, and Pew Charitable Trust. These organizations reported their support of FDA’s implementation of DQSA and urged that “FDA should not be impeded by efforts to carve out exemptions to the law that could allow compounding without prescriptions, outside of limited amounts in anticipation of a prescription, by pharmacies that do not comply with FDA regulations and do not meet appropriate quality standards.”
CMS study raises concerns about access to preferred pharmacy in urban areas
On Dec. 16, CMS released the results of an analysis of beneficiaries’ convenient access to preferred pharmacy networks. The results, which will be released in a final report in 2015, showed that plans are generally providing convenient access to lower cost sharing in suburban and rural areas but some are not providing convenient access in urban areas. CMS indicates that these results support the agency’s concerns regarding access to preferred pharmacies and noted that the agency is considering future policy options. CMS slides on the study, presented to stakeholders in a recent webinar, note that “urban access is a problem.” The study results drew praise from community pharmacists but concerns from PBMs.