I. REGULATIONS, NOTICES, & GUIDANCE
- On August 17, 2015, the Food and Drug Administration (FDA) announced the availability of grant funds for the support of Natural History Database Development. The National Organization for Rare Disorders (NORD) is developing an Internet-based data collection tool with promise to further the accumulation of natural history data for many rare diseases. The goal of this grant is to enable NORD to further develop, refine, and disseminate the database tool. The application due date is September 4, 2015. More information may be found here.
- On August 17, 2015, FDA announced the availability of a draft guidance for industry entitled ‘‘Botanical Drug Development.’’ This guidance describes FDA’s current thinking on appropriate development plans for botanical drugs to be submitted in new drug applications (NDAs) and specific recommendations on submitting investigational new drug applications (INDs) in support of future NDA submissions for botanical drugs. In addition, this guidance provides general information on the over-the-counter (OTC) drug monograph system for botanical drugs. Although this guidance does not intend to provide recommendations specific to botanical drugs to be marketed under biologics license applications (BLAs), many scientific principles described in this guidance may also apply to these products. This draft guidance revises the guidance for industry entitled ‘‘Botanical Drug Products’’ issued in June 2004. Comments are due October 16, 2015.
- On August 17, 2015, FDA announced the availability of the guidance entitled ‘‘Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices.’’ National outbreaks of Toxic Anterior Segment Syndrome (TASS) have been associated with single-use intraocular ophthalmic devices (IODs) and single-use intraocular ophthalmic surgical instruments/accessories that are contaminated with endotoxins. These devices can become contaminated as part of the manufacturing, sterilization, or packaging processes. This guidance document provides recommendations for endotoxin limits as well as endotoxin testing to manufacturers and other entities involved in submitting premarket applications (PMAs) or premarket notification submissions (510(k)s) for different categories of IODs to mitigate future outbreaks of TASS.
- On August 17, 2015, FDA announced the availability of a draft guidance for industry entitled ‘‘Rare Diseases: Common Issues in Drug Development.’’ The purpose of this draft guidance is to advance and facilitate the development of drugs and biologics to treat rare diseases. Drug development for rare diseases has many challenges related to the nature of these diseases. This draft guidance is intended to assist sponsors of drug and biological products for treating rare diseases in conducting more efficient and successful development programs. Comments are due October 16, 2015.
- On August 17, 2015, the Health Resources and Services Administration (HRSA) released a 340 Program Update. The topic page includes information on keys to the recertification process, and ‘340B OnDemand’, a new online educational resource.
- On August 18, 2015, the FDA Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) announced support for the 3.2 of Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model Implementation Guide (SDTM IG 3.2), an update to the FDA Data Standards Catalog (Catalog), and availability of validation rules for the 3.2 version. SDTM IG 3.2 has been available from CDISC since December 2013. FDA is encouraging sponsors and applicants to use SDTM IG 3.2 in investigational study data provided in regulatory submissions to CBER and to CDER. More information may be found here.
- On August 18, 2015, FDA announced the availability of a document entitled ‘‘Providing Submissions in Electronic Format— Post-marketing Safety Reports for Vaccines; Guidance for Industry.’’ The guidance document provides information and recommendations pertaining to the electronic submission of post-marketing safety reports involving vaccine products marketed for human use with approved biologics license applications (BLAs), including individual case safety reports (ICSRs) and attachments to ICSRs (ICSR attachments), into the Vaccine Adverse Event Reporting System (VAERS). VAERS is a national vaccine safety surveillance program that is cosponsored by the Centers for Disease Control and Prevention (CDC) and FDA. FDA published in the Federal Register a final rule requiring that certain post-marketing safety reports for human drug and biological products, including vaccines, be submitted to FDA in an electronic format that the Agency can process, review, and archive. The guidance is intended to help applicants required to submit post-marketing safety reports involving vaccine products to comply with the final rule. The guidance announced in this notice finalizes the draft guidance of the same title, dated July 2014, and supersedes the document entitled ‘‘Guidance for Industry: How to Complete the Vaccine Adverse Event Report System Form (VAERS–1)’’ dated September 1998.
- On August 18, 2015, FDA announced the availability of the guidance entitled ‘‘Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems.’’ FDA has developed this guidance to inform the coronary and peripheral stent industry about selected updates to FDA’s thinking regarding certain non-clinical testing for these devices. While FDA is considering more substantial updates to the ‘‘Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems’’ guidance FDA is issuing this update on select sections in order to notify the industry in a timely manner of the Agency’s revised recommendations.
- On August 18, 2015, FDA announced that the Agency is soliciting nominations for participation in a pilot program for the submission of medical device reports for malfunctions of class I devices and certain class II devices in summary format on a quarterly basis. Under the Medical Device Reporting on Malfunctions pilot program, FDA intends to work with manufacturers to identify candidates for the pilot program and intends to continue to accept nominations until candidates for the pilot program have been selected. FDA will begin accepting nominations for participation in the voluntary pilot program on September 1, 2015, and intends to continue to accept nominations until candidates for the pilot program have been selected. More information may be found here.
- On August 19, 2015, FDA’s Center for Devices and Radiological Health (CDRH), Offices of Device Evaluation (ODE) and In Vitro Diagnostics and Radiation (OIR) announced their participation in the International Medical Device Regulators Forum’s (IMDRF) Regulated Product Submission Table of Contents Pilot Program. Participation in the Pilot is voluntary and open to applicants who submit premarket approval (PMA) applications or premarket notification (510(k)) to either ODE or OIR. The Pilot project is intended to provide industry, IMDRF, and CDRH staff the opportunity to evaluate the Table of Contents structure and to receive input from industry participants. Participants will be asked to submit their submissions electronically using IMDRF’s Table of Contents (ToC) format. The Pilot project will accept submissions with the ToC structure starting September 2015 through September 2016. More information may be found here.
- On August 19, 2015, FDA released a notice entitled “Medical Devices; Export Certificates; Food and Drug Administration Export Reform and Enhancement Act of 1996; Certification Fees”. FDA is announcing the revised fees the Agency will assess for issuing export certificates for devices. The FDA Export Reform and Enhancement Act of 1996 (EREA) provides that any person who exports a device may request FDA certify in writing that the exported device meets certain specified requirements. It further provides that FDA shall issue such a certification within 20 days of the receipt of a request for such certification and that FDA may charge up to $175 for each certification that is issued within the 20 days. Since February 2003, FDA’s costs to process the device certificates have increased; however, the export certificate fee for subsequent certificates has not changed. Because of the increase, FDA is raising the fees for subsequent certificates, from the current fee of $15 to $85, and revising the formula used to calculate the number of original and subsequent device export certificates issued. These changes are necessary to ensure that the program remains self-sustaining and to cover FDA’s increased costs, which are currently being covered by appropriated funds. Further, this document explains the costs associated with the export certification program for devices. The fees described in this document for export certificates for devices will be effective September 1, 2015.
- On August 19, 2015, the Department of Veterans Affairs (VA) solicited comments on the information needed to provide payment of per diem to state homes that provide nursing home care to eligible veterans and payment of per diem to State homes that provide adult day health care to eligible veterans. The intended effect of these provisions was to ensure that veterans receive high quality care in State Homes. Written comments and recommendations on the proposed collection of information should be received on or before October 19, 2015. More information may be found here.
- On August 19, 2015, the Centers for Disease Control and Prevention (CDC) released a notice entitled “Insurance Coverage, Employment Status, and Copayments/Deductibles Faced by Young Women Diagnosed with Breast Cancer—New—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP)”. This notice invites comment on the proposed information collection request entitled ‘‘Breast Cancer in Young Women Survey’’, which is designed to assess insurance coverage, employment status and out-of-pocket health care expenses among young women diagnosed with breast cancer and to look at the relationship between these variables and treatment decisions. Written comments must be received on or before October 19, 2015.
- On August 20, 2015, FDA announced the establishment of a public docket to receive comments from interested parties on enhancing the utility and usability of the Inactive Ingredient Database (IID) (also known as the Inactive Ingredient Guide). These comments will help FDA identify best practices to assist Agency staff in designing the IID and maintaining the information contained therein. The Agency will intend to identify and further develop these best practices in a technical guide or draft guidance to be issued at a later date. Submit either electronic or written comments by October 19, 2015. More information may be found here.
- September 11, 2015: The FDA, in collaboration with the University of Maryland’s Center of Excellence in Regulatory Science and Innovation (M–CERSI) is announcing a public workshop entitled ‘‘Scientific Inquiry Into How Mobile Health and Social Data Sources May Inform Medical Product Safety and Efficacy.’’ The purpose of the public workshop is to discuss important scientific questions about using two of the most ubiquitous and fastest growing data sources, mobile health data and social computing data, focusing especially on the implications for product safety. The event will take place from 12:30 PM to 5:30 PM in College Park, Maryland. More information may be found here.
II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION
- The Senate is out of session during the August recess. Both chambers of Congress are expected to resume regular legislative business on September 8th. The Senate calendar may be found here.
House of Representatives
- The House is out of session during the August recess. Both chambers of Congress are expected to resume regular legislative business on September 8th. The House calendar may be found here.
III. REPORTS, STUDIES, & ANALYSES
- On August 19, 2015 the Georgetown University Center on Health Insurance Reforms published a report entitled “Big Data: A New Paradigm for Health Plan Oversight and Consumer Protection?”. In this issue brief, authors discuss how insurance regulators (primarily state DOIs and the federal Center for Consumer Information and Insurance Oversight, or CCIIO) and third parties are currently using data collection and how it could change under the ACA to improve health plan oversight and compliance. In particular, we discuss how the new ACA requirements could prompt a sea change in regulatory oversight – and counterintuitively – reduce the regulatory burden on health plans. Not included in this brief, however, is a discussion of how data can be used by the general public, i.e., for purposes of comparing and shopping for health plans. We hope to revisit this topic in a future brief.
- On August 19, 2015, the Journal of the American Medical Association (JAMA) published a paper entitled “Efficacy of Liraglutide for Weight Loss Among Patients with Type 2 Diabetes”. The article describes the results of a fifty-six week randomized double-blind placebo-controlled trial with 12-week observational off-drug follow-up period to investigate the efficacy and safety of liraglutide (Saxenda) versus placebo for weight management in adults with overweight or obesity and type 2 diabetes. The results demonstrated that among overweight and obese participants with type 2 diabetes, use of subcutaneous liraglutide daily, compared with placebo, resulted in weight loss over 56 weeks.
IV. OTHER HEALTH POLICY NEWS
- On August 19, 2015, Arkansas Governor Asa Hutchinson announced in an address that he favors keeping the state’s alternative Medicaid expansion program, under certain conditions.
- On August 21, 2015, the U.S. Court of Appeals for the D.C . Circuit ruled that regulations that extend minimum-wage and overtime provisions to millions of employees nationwide who provide home health through a third-party agency are a reasonable interpretation of the Fair Labor Standards Act. “Individuals with significant care needs increasingly receive services in their homes rather than in institutional settings,” the opinion said. “And correspondingly, residential care increasingly is provided by professionals employed by third-party agencies rather than by workers hired directly by care recipients and their families.”
- On August 20, 2015, the Medicare Payment Advisory Commission (MedPAC) published a comment letter on CMS’s proposed rule on the Comprehensive Care for Joint Replacement payment model for acute care hospitals. On August 18th, the Commission published a comment on CMS’ proposed rule on the home health prospective payment system, available here.