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By Danielle H. Capilla, JD -- Wolters Kluwer Contributor /
August 26, 2014 /
Posted in: HLI News, HLI Affordable Care Act /
The FDA provides basic tracking information of each applicable section of the ACA on its “FDA-TRACK Health Care Reform Dashboard,” a subset of its “FDA-TRACK” agency-wide program, which promotes “TRACK”—Transparency, Results, Accountability, Credibility, and Knowledge-sharing. At one point the agency was providing quarterly briefing summaries through FDA-TRACK as it related to health care reform, but the last briefing was provided in June of 2012.
Section 3507 Prescription Drug Labeling
Section 3507 of the ACA directs the Secretary of HHS to determine if the addition of quantitative summaries on the risks and benefits of a prescription drug, added to the label of a drug and provided in a standardized format, would help improve health care decisions for providers, patients, and consumers. The Secretary was tasked with providing a report to Congress within a year of passage of the ACA. Under sec. 3507, if the Secretary determines that these risk and benefit summaries are warranted, the Secretary has three years to issue proposed regulations to implement the new format.
Congressional report. In March of 2011, Commissioner Hamburg submitted a report to Congress stating that the FDA did not have research with a sufficient scientific basis to support a decision at that time. The agency estimated it would take three years to conduct studies, review literature, and consult with experts. The studies were underway at the time of the report, and a detailed timeline was provided. The FDA stated it would provide Congress with annual progress reports and would have a final determination in the fall of 2013. The final report has yet to be submitted, despite FDA-TRACK stating it is “on track” for the Fall-Winter of 2013 with a September 30, 2013, deadline.
Milestones. The agency identified seven milestones related to sec. 3507 between the first and final report. Those milestones all have been completed, although some of the later ones, such as the final report, were behind schedule. The milestones were: (1) receive draft literature review summarizing scientific evidence and research on decision making and social and cognitive psychology; (2) present results of the literature review to the FDA Risk Communications Advisory Committee for its review and recommendations: (3) complete quantitative research study on the value of adding quantitative information to direct-to-consumer (DTC) print and television advertisements; (4) complete display page research study of how physicians and consumers make risk benefit assessments and how consumers make such assessments in response to variations in the display page of DTC print ads; (5) complete format research study of the type of information that could be presented in a standardized "box" and how qualitative information might be included; (6) submit second progress report to Congress; and (7) submit third progress report to Congress. Although the first two milestones were completed on time, the remaining five were not. The third progress report was submitted on June 6, 2013, despite a deadline of March 31, 2013.
Delayed reports. An unpublished Congressional Research Service memo dated June 5, 2013, noted that implementation of sec. 3507 was in progress and the agency had indicated it would provide Congress with annual reports. The second and third Congressional reports remain unpublished. Stephen King, a member of the CDER Press Trade Team of the FDA, told Wolters Kluwer the final Congressional report is slated to be issued in the spring of 2014.
Section 10609 Generic Drug Labeling
Section 10609 of the ACA provided that an abbreviated new drug application (ANDA) (generic drug) with a proposed label that is different from the label of the originator, reference drug product (brand name drug) will remain eligible for approval if the “Warnings” section isn’t changing and the ANDA sponsor agrees to submit a revised label within 60 days of notification. The changes updated sec. 505(j) of the Food, Drug and Cosmetic Act (FDC) Act. Previously, a generic drug’s approval could be delayed if the reference drug product’s sponsor made a change to the reference drug’s label shortly before the generic drug was approved.
Congressional intent. Section 10609 is intended to provide for faster approval of generic drugs and prevent brand name drug manufacturers from delaying approval of generic versions. Elese E. Hanson, JD, an associate at Katten Muchin and Rosenman LLP, spoke with Wolters Kluwer and stated that she believes that sec. 10609 strikes an appropriate balance of not discouraging legitimate labeling amendments by the brand company, which may serve to benefit the physician and/or patient, while also protecting the generic company that has often won the right to bring its product to the market without further unnecessary delay. Ms. Hanson noted a popular example behind the implementation of sec. 10609 was AstraZeneca’s label change in the pediatric section of the label of Casodex®, a prostate cancer drug. The change in the pediatric label led to a three month delay in generic approval.
Milestones. Implementation of sec. 10609 was divided into three milestones: (1) draft revisions to the ANDA approval letter so that when necessary, the letter can serve as notification of a labeling change to the reference listed drug; (2) implement changes to the Document Archiving, Reporting and Regulatory Tracking System (DARRTS) database to allow tracking of post-approval commitments to revise a generic drug label; and (3) Draft a Manual of Policy and Procedures (MaPP) for the Office of Generic Drugs to describe the process used to ensure full and consistent implementation.
All three of these milestones were listed as being completed on time, with the MaPP being given a December 22, 2010, completion date in FDA-TRACK. Despite the 2010 completion date, the MaPP was not published for the public until February 12, 2013.
Section 4205 Menu Labeling
Section 4205 of the ACA provided that the calorie content of standard menu items, other nutritional information, and the suggested daily calorie intake be placed directly on menus and menu boards of restaurants, retail food establishments, and vending machine operations that are part of chains with 20 or more locations. Prior to the ACA, sec. 403(q) of the federal FDC Act required nutritional information be provided on food for sale but exempted restaurants and food provided for immediate consumption.
Four part process. According to FDA-TRACK, the agency divided the implementation of sec. 4205 into a four-part process. The first, completed in the summer of 2010, was to publish a Federal Register notice for comments and voluntary registration conditions pending final regulations. The second part of the process was to develop guidances for the industry on implementation of sec. 4205. A final guidance on the section and its impact on state and local laws were published in August of 2010. A draft guidance on the implementation of self-executing requirements of sec. 4205 on standard menu items was published, comments were reviewed, and the draft guidance was subsequently withdrawn in December of 2011. The third part of the process was to develop final regulations in relation to restaurants, which included publishing aproposed rule on April 6, 2011, reviewing comments, summarizing the comments, and preparing and publishing a final rule. The preparation and publishing of the final rule has been delayed since June of 2012. The fourth part of the process was to develop final regulations for vending machine items. Similarly, although the vending machineproposed rule was published on April 6, 2011, the preparation and publication of the final rule has been delayed since June of 2012. The agency has provided a Q&A sheeton the proposed rules.
Response. The response to menu labeling has been varied. In 2013, legislation was introduced in both the House and the Senate titled the “Common Sense Nutrition Disclosure Act,” which would exempt pizza delivery businesses and grocery stores from falling under the umbrella of sec. 4205. H.R. 1249 and S. 1756 have both been referred to committees. Some lawmakers reportedly have asked Congress to limit the scope of the regulations, arguing that small businesses are already tasked with complying with the 1990 Nutrition Labeling and Education Act (NLEA).
In 2011, the city of Philadelphia filed a citizen petition seeking an exemption from the menu labeling requirements, arguing that its regulations are largely consistent with the new federal requirements, and actually require more information than the federal ones. In support of its petition, the city contended that its stricter requirements led to reduced portion sizes or calorie content in response to the growing awareness of nutrition information. On the technological front, one company has responded to the eventual final regulations by creating a vending machine that can provide nutritional information on an LCD screen, which it claims is easily readable for the consumer.
Generally, FDA-provided information on ACA implementation does not appear to be accurately reflected on its website, while some information, such as Commissioner Hamburg’s progress reports regarding potential drug labeling changes, is not provided at all. Although FDA-TRACK is available to the industry, it provides only cursory information.
Although the FDA has worked at incorporating ACA changes into its regulatory framework, the agency is behind schedule on a variety of projects, most notably in regard to prescription drug labeling changes, and publication of final regulations on menu labeling and vending machine labeling.
Drug manufacturers do not know if significant labeling changes lie ahead, so they are unable to strategize the implementation of those changes. Similarly, the restaurant and vending machine industry, which will incur significant cost to redo signage and upgrade technology, is unable to make decisions or employ budget strategy until the final regulations are released.
Attorneys: Elese E. Hanson (Katten Muchin and Rosenman LLP)
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