By Kurt R. Karst –
A Draft Committee Report made available by the U.S. House of Representatives Committee on Appropriations that would, once finalized, accompany the Fiscal Year 2014 Agriculture/FDA Apprropriations bill (currently available as a Full Committee Draft), lays out a laundry list of concerns and new action items for FDA to meet.
Below we categorize each of the items in the Draft Committee Report. Many of the items concern issues currently being debated in Congress, and, more broadly, within the food and drug-regulated industry.
Transparency Concerns.—The Committee is concerned about the unpredictable nature and pace at which FDA moves guidance, rules, and regulations through the process. The Agency must understand that FDA is often viewed as a primary source of information for consumer decisions that impact their health and wellbeing. The Committee understands that many rules and regulations get through the agency and the department only to languish at the Office of Management and Budget (OMB). On the other hand, FDA has discretion to issue advisories and guidance without the need for OMB clearance. In a number of critical health areas, American consumers and industry are faced with no guidance at all or inconsistent messages on many important issues. The following is a list of examples: seafood advisory for pregnant women; sunscreen ingredients; new dietary ingredients for dietary supplements; and, Bisphenol A. The Committee directs FDA to report to the Committees on Appropriations by September 1, 2013, on how the agency plans to develop new methods of communicating with its stakeholders on future actions affecting critical policy issues, including estimated timeframes for when regulations, advisories, and guidance are planned for release and what decision points are necessary before these policy documents can be made.
Low-Risk, Expedited Imports.—The current fiscal environment and the growing number of import entries require that efforts to enhance safety must be directed towards the most serious compliance infractions. The Committee strongly encourages FDA to establish a pilot project to expedite imports for importers with strong safety records. Such project could be modeled on the Customs and Border Protection (CBP) Customs-Trade Partnership Against Terrorism and Importer Self-Assessment programs which address security of imported products. The goal would be new trade facilitation methods for low-risk importers that provide accurate and reliable data, have a history of importing compliant products, and low risk cargo that could be incorporated into the import inspection process, thereby enabling FDA to better leverage financial resources. FDA is strongly encouraged to provide clear guidelines for those importers that are low-risk and to collaborate with CBP and other relevant agencies to enhance information sharing between agencies on this work. FDA is directed to provide a report to the Committee on its efforts in this regard by December 1, 2013.
Statutory Deadlines.—The Committee is aware the Administration continues to miss statutory deadlines for rulemaking to implement Public Law 111–353. The Committee expects the Administration to meet the statutory timelines for implementing Public Law 111–353 and directs FDA to provide a report every 180 days detailing the reasons and justification for any proposed rule or final regulation being 120 days or more beyond its statutory deadline.
FDA User Fee Collections/Obligations.—The Committee is concerned about the large unobligated balances that continue to occur in FDA’s user fee programs. While Congress did allow for some exemptions from fiscal year limitations and for some amounts to be carried forward into subsequent fiscal years, it could not have been anticipated that FDA would be carrying in excess of $1,000,000,000 in unobligated user fees halfway into any fiscal year. In the Tobacco user fee program alone, the fiscal year 2012 unobligated balance that carried over into fiscal year 2013 was $600,000,000. While FDA estimates this figure will drop to $250,000,000 by the end of fiscal year 2013, the Committee remains skeptical that this will occur. The Committee directs that not later than November 1, 2013, and each month thereafter through the months covered by this Appropriations Act, the Commissioner to submit to the Committees on Appropriations of the House and the Senate a report on user fees collected for each user fee program included in the bill. The report shall also include monthly obligations incurred against such fee collections. The first report shall include a distinct categorization of the user fee balances that are being carried forward into fiscal year 2014 for each user fee account as well as a detailed explanation of what accounts for the balance and what the balance will be used for.
User Fees.—The Committee is concerned about subjecting FDA user fees to sequestration as these fees are not normal tax revenue. It is important to maintain the integrity and industry support for user fee programs. The Committee encourages FDA to reevaluate its calculations of sequestration in regard to user fees.
Impact on Small Businesses.—The Committee is concerned by unintended consequences of the Generic Drug User Fee Act (GDUFA) fee structure. While the Committee understands that user fees provide the resources to facilitate generic drug approvals, the Committee believes FDA should study the impact of smaller generic manufacturers’ ability to pay at the same level as large manufacturers. The Committee directs FDA to provide a report to the Committees on Appropriations on the impact of the GDUFA fee structure on smaller generic drug manufacturers within 180 days of enactment of this Act.
Prescription Drugs & Biologics (Human)
Non-Tropical Diseases (NTD).— [NOTE: The reference to "Non-Tropical Diseases" should probably be a reference to "Neglected Tropical Diseases."] The Committee has become aware that Chagas disease is not on the list of neglected diseases as currently defined by FDA. The Committee urges FDA to make the necessary modifications to include Chagas disease in its list of neglected diseases in line with World Health Organization’s list of NTDs. Additionally, the Committee directs that FDA build stronger partnerships with global regulatory stakeholders and strengthen its internal capacity to review products for neglected diseases.
Food and Drug Safety and Innovation Act.—The Committee is aware that shortages of critical drugs persist following the enactment of the Food and Drug Safety and Innovation Act. Surveys conducted by the American Association of Nurse Anesthetists, the American Hospital Association, and the American Society of Health-System Pharmacists report persistent shortages of drugs used in anesthesia care, oncology, and other services, owing primarily to problems in manufacturing, which impair patient access to care and patient experiences in the healthcare system, delay surgical procedures, and possibly increase overall healthcare costs. The Committee directs the Commissioner to continue to prioritize the public reporting of manufacturing shortages and to work with industry to prevent conditions that might lead to drug shortages.
Compounded Drugs.—The Committee is concerned by the quantity and volume of recalls of compounded sterile products and therapies. The Committee awaits the results of a study by GAO providing updated information on state and Federal oversight of compounding. Furthermore, the Committee encourages FDA and the States to work together to improve and strengthen oversight and enforcement of compounding pharmacies.
Abuse-Deterrent Drugs.—The Committee supports FDA’s recent efforts to ensure that certain opioids are kept off the market and commends the agency for removal of those products for reasons of safety or effectiveness. The Committee understands that FDA established draft guidance in January 2013 entitled Evaluation and Labeling of Abuse-Deterrent Opioids, and encourages the agency to move expediently to finalize such guidance.
Prescription Drugs & Biologics (Animal)
Guidance for Industry.—The Committee directs the Secretary of Health and Human Services to finalize Guidance for Industry (GFI) #213 prior to January 1, 2014. The Committee directs the Secretary of Health and Human Services to publish a report not later than one year following the date of finalization of GFI #213 that (1) lists the following, for each medically important antimicrobial new animal drug administered in feed or water to food-producing animals with one or more approved production claims (including any growth promotion, feed efficiency, or weight gain claims) and/or that are approved for over-the-counter (OTC) marketing, provided that such antimicrobial is in a class of drugs that FDA determines accounts for 10 percent or more of all physician prescriptions: (a) the drug’s new animal drug application (NADA) number(s), (b) sponsor, (c) all antimicrobial active ingredients contained in the drug, and, (d) all production claims approved for the drug; and (2) specifies the number of sponsors of the new animal drugs listed that have notified the FDA of their intent to participate in the voluntary process described in GFI #213. The Committee further directs the Secretary, beginning not later than one year following the finalization of GFI #213, to publish annual reports that (1) specify the number of antimicrobial new animal drugs for which sponsors have submitted applications under GFI #213 to change existing approvals, broken out by type of change sought (i.e., removal of production claims; addition of treatment, control, and/or prevention claims; and removal of OTC marketing status); and (2) list the applications submitted under GFI #213 that have been approved by the agency by NADA number, and if not approved or rejected, indicate whether the inaction was a result of insufficient FDA resources, insufficient information from sponsors or some other reason.
Data Collection.—To assist efforts intended to address antibiotic use, the Committee directs the Secretaries of Health and Human Services and Agriculture to require appropriate agencies to collaborate to (1) identify approaches for collecting detailed data on antibiotic use in food-producing animals, (2) seek stakeholder and broad public input to develop a proposal for collecting this information, and (3) use the data to assess the effectiveness of policies to curb antibiotic resistance. The Committee further directs FDA to ensure that ARS continues to analyze, characterize, and report on data collected through NARMS.
Foods & Dietary Supplements
Nutrition Labeling.—The Committee remains concerned with FDA’s proposed rule to regulate Nutrition Labeling of Standard Menu Items at Chain Restaurants. The Committee urges FDA to use the proposed alternative Option 2 definition of the rule which only applies to restaurants or retail establishments where the primary and majority of business is the selling of food for consumption or the selling of food that is processed or prepared on the premises. The Committee believes the agency should take into account the increased costs and logistical challenges chain restaurants will face in meeting the requirements of the proposed rule. To meet the requirements of the law, FDA should consider a clear, conspicuous statement of required nutritional information on a prominently displayed poster adjacent to the menu board and nutritional information to be provided in pamphlet form prominently displayed next to drive-through menu boards as meeting such requirements.
Food safety monitoring.—The Committee notes that the National Agriculture and Food Defense Strategy Plan is being finalized as required by Section 108 of Public Law 111–353. As research needs are identified to carry out this section, the Committee encourages FDA to consider funding research that would provide portable and technologically advanced testing platforms needed to effectively monitor and protect against intentional adulteration of the food supply.
New dietary ingredients.—The Committee notes that FDA has not addressed issues relating to its July 2011 draft guidance on New Dietary Ingredients (NDI) for Dietary Supplements despite this Committee’s urging it to do so last year. The Committee continues to be concerned that this guidance is being utilized by FDA for enforcement activities despite the document only being draft guidance. The Committee directs FDA to report back within 60 days of enactment of this Act with a timeline on how it intends to re-engage the dietary supplement community to develop a final guidance on what constitutes a NDI.
Food Safety Centers of Excellence.—The funding provided for CFSAN supports the base funding for the CFSAN Centers of Excellence at the FY 2011 level, including Food Safety Modernization Act collaborative efforts with these Centers. The Committee encourages FDA to maintain an appropriate funding level for both Food Safety Modernization Act related and other food safety related activities performed by these Centers of Excellence.
Food and Veterinary Medicine.—The Committee is aware of the important support provided to FDA’s food and veterinary medicine programs and through its research and program relations with their centers of excellence. The Committee encourages FDA to maintain an appropriate funding level for both Food Safety Modernization Act related activities and the base work performed by these centers.
Food Product Tracing.—Pursuant to Section 204 of the Food Safety Modernization Act, FDA initiated pilot projects for improving product tracing along the food supply system and the establishment of recordkeeping requirements for high-risk foods. These pilots were conducted by the Institute of Food Technologists, in consultation with various industry sectors, USDA, state agencies, and consumer groups. A report on these projects was published on March 4, 2013, and that report affirmed that industry and government continue to pursue traceability goals on separate tracks and with little collaboration. The Committee directs the Commissioner, in consultation with the Secretary of Agriculture, to create a science-based, international food traceability initiative through a collaborative public-private partnership model. Furthermore, the Committee directs the Commissioner to provide a report within 180 days of enactment of this Act detailing the structure, goals, and implementation status of such traceability initiative.
Seafood Advisory.—FDA must publish a final seafood advisory in conjunction with all applicable parties as directed in House Report 112–101 and Senate Report 112–73. The advisory must be consistent with USDA’s dietary guidelines and be completed and available to the public by June 30, 2013.
Canned Tuna.—The Committee directs FDA to revise the standard of identity for canned tuna to adopt the drained weight fill of container standard as requested in the 1994 ‘‘Citizens Petition to Amend Canned Tuna Standard of Identity, 21 CFR 161.190, Docket No. 94P–0286.’’ According to the Congressional Research Service, the United States is the only country that uses the pressed cake weight fill of container standard that requires outdated 1950s technology. CODEX, the Association of Official Analytical Chemists, and all other countries use the drained weight fill of container. FDA shall revise the standard of identity for canned tuna to replace the pressed cake weight method with the drained weight method by December 31, 2013. FDA shall approve temporary marketing permits that adopt the drained weight method consistent with international standards until such time as final regulations are published updating the standard of identity for canned tuna.
Over-the-Counter Drugs & Cosmetics
Sunscreen.—Approximately two million cases of skin cancer are diagnosed each year and an estimated one in five Americans may develop skin cancer during their lifetime. Since sunscreen use can help prevent this disease, the Committee is concerned that FDA has taken no final action to approve new sunscreen ingredients under the Time and Extent Applications (TEA) process. The Committee understands that new sunscreen ingredient TEAs have been pending at FDA for more than 10 years without any approvals despite their widespread safe and effective use in other countries. FDA has listed final action on sunscreen ingredient applications in its Unified Agenda every year since 2008; however, no such action has ever been taken. Therefore, FDA shall take final action on all sunscreen ingredient applications currently pending by June 1, 2014, and shall work with Congress and stakeholders—including ingredient manufacturers, finished product manufacturers, dermatologists, cancer prevention organizations and others—to develop a new process that will allow safe and effective sunscreen ingredient market applications to receive a final decision from FDA within one year of application date.
Cosmetics.—The Committee directs the Office of Cosmetics and Colors to respond by September 30, 2013, to a citizen petition setting safety levels for trace amounts of lead in cosmetics.
Cough and Cold Products for Children.—The Committee is concerned that FDA has not issued a proposed rule revising the monograph regulating the labeling of over-the-counter cough and cold products for children. The Committee directs the agency to publish a proposed rule by December 31, 2013, based on scientific evidence for safety and efficacy in pediatric populations and taking into consideration the October 19, 2007, joint recommendations of its Pediatric Advisory Committee and Nonprescription Drugs Advisory Committee.
Medical Devices & radiological Health
Mammography Quality.—The Committee urges FDA to follow up the November 2011 meeting of the National Mammography Quality Assurance Advisory Committee by promptly reviewing the evidence supporting including information related to an individual’s breast density in the mammogram patient report and physician report.
Regulations.—The Committee appreciates FDA’s acknowledgement that exclusive tobacco products may raise different questions of public health and may need to be treated differently. Further, the Committee notes that there are key differentiating and unique characteristics of premium cigars and that any effort to bring these products under the ‘‘deeming’’ rule should proceed with these factors being taken into consideration.
Center for Tobacco Products Performance.—The Committee understands that GAO is conducting a study of FDA’s premarket review of tobacco products. The Committee directs that, upon publication of that study, FDA shall use it to identify a set of regulatory performance standards that will address pending and new substantial equivalent applications, pending and new modified risk applications, citizen petitions, and meeting requests. The Committee further directs FDA to report to the Committees on Appropriations by March 31, 2014, on the implementation of such performance standards.