DIA's Content Currents provides you with new and important global regulatory developments and their impact on pharmaceutical, biotechnology, and medical product development.
EDITION PUBLISHED: March 7, 2013
SECTION 1 FDA GUIDANCES & MAPPS
CDER 2014 New & Revised Draft Guidance Agenda
Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2014 (PDF - 31KB)
CDRH FY 2014 Proposed Guidance Development
On March 5, 2014, FDA announced the availability of a guidance entitled ‘‘CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports.’’
This guidance provides recommendations to holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding the types of changes to be documented in annual reports. Specifically, the guidance describes chemistry, manufacturing, and controls (CMC) postapproval manufacturing changes that FDA has determined will likely have a minimal potential to have an adverse effect on product quality and, therefore, should be documented by applicants in an annual report. (The guidance excludes positron emission tomography drug products.) [Federal Register
On March 5, 2014, FDA announced the availability of the guidance entitled “Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients With Disorders Affecting the Hematopoietic System.”
The guidance document provides advice to potential sponsors, such as cord blood banks, registries, transplant centers, or individual physicians serving as sponsor-investigators, to assist in the submission of an investigational new drug application (IND) for certain hematopoietic progenitor cells from placental/umbilical cord blood (HPC, Cord Blood), when such HPC, Cord Blood units are not licensed, and when a suitable human leukocyte antigen (HLA) matched cord blood transplant is needed for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment and there is no satisfactory alternative treatment available. [Federal Register
On March 5, 2014, FDA announced the availability of the guidance entitled “Guidance for Industry and FDA Staff: Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients With Disorders Affecting the Hematopoietic System.”
The guidance document provides recommendations for manufacturers, generally cord blood banks, to apply for licensure of minimally manipulated, unrelated allogeneic placental/umbilical cord blood, for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment. The guidance document is intended to assist manufacturers in obtaining a biologics license. [Federal Register
On March 3, 2014, FDA announced the availability of a draft guidance entitled “Distributing Scientific and Medical Publications on Unapproved New Uses—Recommended Practices.”
This draft guidance revises the final guidance titled ‘‘Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices’’ published in January 2009. To ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 2, 2014. [Federal Register
On February 28, FDA posted a notice of correction to a guidance for industry entitled ‘‘Providing Regulatory Submissions in Electronic Format—Receipt Date.’’
FDA is correcting a notice that appeared in the Federal Register of Friday, February 7, 2014 (79 FR 7463). The document announced the availability of a guidance entitled ‘‘Providing Regulatory Submissions in Electronic Format—Receipt Date.’’ The document was published with an incorrect Web site in the ‘‘Electronic Access’’ section. This document corrects that error. [Federal Register
On February 28, 2014, FDA announced the availability of a draft guidance entitled ‘‘Attachment to Guidance on Antiviral Product Development—Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HIV–1 Resistance Data.’’
The purpose of this guidance is to assist sponsors in submitting human immunodeficiency virus (HIV) clinical virology data that are important for supporting clinical trials of products in development for the treatment of HIV. HIV resistance data submitted in appropriately formatted datasets are critical components in the review of investigational antiviral products for the treatment of HIV. This draft guidance revises the guidance for industry entitled ‘‘Attachment to Guidance on Antiviral Product Development—Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HIV Resistance Data’’ issued on June 5, 2006. Comments should be submitted by April 29, 2014. [Federal Register
On February 27, 2014, FDA announced an opportunity for public comment on the proposed collection of information by the Agency on “Prescription Drug Advertising.”
Comments are solicited on the proposed collection of certain information pertaining to the reporting requirements, including third party disclosure, contained in FDA’s current regulations on prescription drug advertisements. Comments are requested by April 28, 2014. [Federal Register
On February 26, 2014, FDA announced the availability of a draft guidance entitled ‘‘Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation To Treat Clostridium difficile Infection Not Responsive to Standard Therapies.’’
This draft guidance informs members of the medical and scientific community and other interested persons that FDA intends to exercise enforcement discretion regarding the investigational new drug (IND) requirements for the use of fecal microbiota for transplantation (FMT) to treat C. difficile
infection not responding to standard therapies when specific criteria are met. This draft guidance, when finalized, is intended to supersede the guidance document entitled ‘‘Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile
Infection Not Responsive to Standard Therapies,’’ dated July 2013 (July 2013 Guidance). Comments should be submitted by March 28, 2014. [Federal Register
SECTION 2 FDA NOTES & RELATED NEWS
Web-Based Resources For Industry, Patients, and Advocacy Groups Developing Products for Rare Diseases and Conditions
In recognition of Rare Disease Day 2014, FDA is pleased to launch recorded educational topics about FDA and rare disease issues. Our goal is to make these educational resources accessible to a broad audience. These educational resources are meant to serve as a beneficial tool to all rare disease stakeholders, and additional cross-cutting rare disease topics will continue to be added to this webpage over time. The title link above leads to the multiple stakeholder page, and a consumer-oriented page is located at Innovation in Rare Disease Therapies
Notice to Public of Web Site Location of Report to Congress: Report on the FDA’s Policy To Be Proposed Regarding Premarket Notification Requirements for Modifications to Legally Marketed Devices
FDA is announcing the Web site location where the Agency has posted the report entitled ‘‘Report to Congress; Report on FDA’s Policy to be Proposed Regarding Premarket Notification Requirements for Modifications to Legally Marketed Devices.’’ No later than 18 months after enactment of FDASIA, the Secretary of Health and Human Services is required to submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on when a premarket notification under section 510(k) of the FD&C Act (or a ‘‘510(k)’’) should be submitted for a modification to a legally marketed 510(k) device. This report fulfills that requirement. In addition, FDA has established a docket where stakeholders may provide comments. (Comments due by June 4, 2014.) (Federal Register
Filing of Closed Advisory Committee Meeting Reports
FDA is announcing that, as required by the Federal Advisory Committee Act, the Agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2013. The specific meeting reports that will be accessible for review at the Library of Congress and also at the Division of Dockets Management (Rockville, MD) are listed in the Federal Register notice linked above. (Federal Register
FDA Third Progress Report to Congress on Implementation of Section 3507 of the ACA
FDA has posted the third and final annual report to Congress (dated June 2013) on progress made toward fulfilling requirements of Section 3507 of the Patient Protection and Affordable Care Act of 2010. In this report, FDA summarizes its progress toward determining whether the addition of quantitative, standardly formatted summaries of the benefits and risks of prescription drugs to promotional labeling or print advertising would improve health care decision-making by clinicians and patients and consumers. The Agency also reports its progress in considering research in the areas of social and cognitive psychology and in consulting stakeholders and experts in health literacy. The report indicates that the necessary studies, literature review, and consultation with experts were well underway and provides an updated timeline for completion of the work. More at link above. (FDA.gov)
Planning Healthy Changes to the Nutrition Facts Label
In her February 27 blog on FDA.Voice, Dr. Margaret Hamburg discussed FDA’s proposed changes to the Nutrition Facts Label that will reflect changes in knowledge about food consumption, nutrition, and population health in order to facilitate educated decision making by consumers about dietary choices. The blog includes a link to the FDA website where labels in the current and proposed formats are compared side by side, and the proposed changes and rationale are detailed. More at link above. (FDA.gov)
FDA Announces CBER's Move to White Oak Campus
FDA) is announcing that the Center for Biologics Evaluation and Research (CBER) will be moving its offices and laboratories from various Rockville and Bethesda, MD, locations to the FDA White Oak campus in Silver Spring, MD. The move will commence on or about May 1, 2014, and will end approximately 8 weeks later, on or about July 1, 2014. More at link above. (Federal Register
SECTION 3 AGENCY AND ADVISORY COMMITTEE MEETINGS
Patient-Focused Drug Development: Disease Area Meetings Planned for FY2013-2015
Public Workshop. IOM Workshop: “Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks in Drug Regulatory Decision-Making.” February 12-13, 2014.
The purpose of the workshop is twofold: To explore potential approaches to addressing and communicating uncertainty and to identify key considerations on developing, evaluating, and incorporating potential approaches for addressing uncertainty into the assessment of benefits and risks in the human drug review process. The format of the meeting consists of a series of presentations on topics related to uncertainty in the assessment of benefits and risks, followed by a discussion on those topics with invited panelists and audience members. This workshop satisfies an FDA commitment that is part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). Federal Register Note: Due to impending inclement weather, DAY 2 of this meeting, February 13th, focusing on communication of uncertainty, will be postponed and rescheduled for the spring (tentatively April or May). The new workshop date will be announced via email and will be posted on the FDA and IOM meeting websites.
Public Meetings on Proposed Rule. Focused Mitigation Strategies To Protect Food Against Intentional Adulteration. February 27, 2014 (Chicago, IL); March 13, 2014 (Anaheim, CA).
FDA is announcing two public meetings to discuss the proposed rule to require domestic and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to address hazards that may be intentionally introduced by acts of terrorism. FDA proposed these requirements as part of our implementation of the FDA Food Safety Modernization Act (FSMA). [Federal Register
Public Workshop. Application of Physiologically-Based Pharmacokinetic Modeling To Support Dose Selection. March 10, 2014.
The purpose of the workshop is to obtain input on scientific approaches for the conduct and assessment of physiologically-based pharmacokinetic (PBPK) modeling within the framework of drug development and regulatory decision-making. The input from the workshop may be used to refine FDA’s thinking on the various applications of PBPK. Preliminary elements of a draft concept paper will be presented to facilitate discussion at this public workshop. [Federal Register
Public Conference. Serious Drug-Induced Liver Injury: Who Gets It? Who Doesn’t? Why? March 19-20, 2014. Hyattsville, MD.
This conference will be cosponsored with the Critical Path Institute (C-Path) and the Pharmaceutical Research and Manufacturers of America. Its purpose is to discuss, debate, and share views among stakeholders in the pharmaceutical industry, academia, health care providers, patient groups, and regulatory bodies on how best to detect and assess the severity, extent, and likelihood of drug causation of liver injury and dysfunction in people using drugs for any medical purpose. [Federal Register
Public Advisory Committee Meeting. Vaccines and Related Biological Products Advisory Committee. March 20, 2014. Rockville, MD.
(The public is welcome to attend the meeting at the specified location where a speakerphone will be provided.) The committee will meet in open session to hear updates of the research programs in the Laboratory of Respiratory and Special Pathogens, Division of Bacterial, Parasitic and Allergenic Products, and in the Laboratory of Hepatitis Viruses, Division of Viral Products, CBER, FDA. At least one portion of the meeting will be closed to the public. [Federal Register
Public Hearing. Over the Counter Drug Review. March 25-26, 2014. White Oak Campus, Silver Spring, MD.
The Agency would like input on how to improve or alter the current OTC Monograph Process for reviewing nonprescription drugs (sometimes referred to as OTC drugs) marketed under the OTC Drug Review. This public hearing is being held to obtain information and comments from the public on the strengths and weaknesses of the current OTC Monograph Process, and to obtain and discuss ideas about modifications or alternatives to this process. [Federal Register
Rescheduled Date. Public Meeting. FDA Patient Focused Drug Development: Fibromyalgia. March 26, 2014.
The public meeting is intended to allow FDA to obtain patients’ perspectives on the impact of fibromyalgia on daily life as well as the available therapies for fibromyalgia. [Federal Register
Stakeholders Meeting. International Medical Device Regulators Forum (IMDRF). March 26, 2014. San Francisco, CA.
All interested parties are invited to attend this full day open session. Meeting participants will be invited to discuss how they contribute to continuous improvements of products safety and performance, and how they face the emerging challenges. Stakeholders’ input is important to effective progress on harmonization issues. [FDA Meeting Notice
Rescheduled: Public Workshop: Synergizing Efforts in Standards Development for Cellular Therapies and Regenerative Medicine Products. March 31, 2014. FDA White Oak Campus. Silver Spring, MD.
The purpose of the public workshop is to bring together a broad range of stakeholders to discuss current and future standards development activities involving cellular therapies and regenerative medicine products. This public workshop was postponed in October 2013 due to the government shutdown. [Federal Register
New: Public Workshop. Advancing Regulatory Science for High Throughput Sequencing Devices for Microbial Identification and Detection of Antimicrobial Resistance Markers. FDA White Oak Campus. Silver Spring, MD.
The purpose of the public workshop is to discuss the clinical and public health applications and performance validation of these devices, the quality criteria for establishing the accuracy of reference databases for regulatory use and ways to streamline clinical trials for microbial identification. [Federal Register
New: Public Hearing. Action Plan for the Collection, Analysis, and Availability of Demographic Subgroup Data in Applications for Approval of Food and Drug Administration-Regulated Medical Products. April 1, 2014. FDA White Oak Campus, Silver Spring, MD.
The purpose of the public hearing is to obtain input on the issues and challenges associated with the collection, analysis, and availability of demographic subgroup data in applications for approval of FDA-regulated human medical products. [Federal Register
New: Public Advisory Committee Meeting. Risk Communications Advisory Committee. May 5-6, 2014. FDA White Oak Campus, Silver Spring, MD.
The committee will meet to discuss methods for identifying the impact and increasing the reach of communications on topics of interest to consumers. The discussion will also address how FDA can evaluate whether its Consumer Updates (ForConsumers/ConsumerUpdates
) are reaching the targeted population, and whether they are increasing awareness and understanding of the key risk messages. The discussion will also assess whether the communications are having the intended impact on knowledge, behaviors and/or outcomes. [Federal Register
New: Public Hearing. Generic Drug User Fee Amendments of 2012: Regulatory Science Initiatives. May 16, 2014. FDA White Oak Campus, Silver Spring, MD.
The public hearing will provide an overview of the current status of regulatory science initiatives for generic drugs and an opportunity for public input on research priorities in this area. FDA will take the information it obtains from the public hearing into account in developing the fiscal year (FY) 2015 Regulatory Science Plan. [Federal Register
Public Meeting. Study Approaches and Methods to Evaluate the Safety of Drugs and Biological Products During Pregnancy in the Post Approval Setting. May 28-29, 2014. FDA White Oak Campus, Silver Spring, MD.
The purpose of the public meeting is to engage in constructive dialogue and information sharing among regulators, researchers, the pharmaceutical industry, public health agencies, health care providers, and the general public concerning challenges in designing and implementing pregnancy registries and other methods of evaluating the post-approval safety profile of drugs and biological products in pregnant women. The input from this meeting and public docket will be used to support the revision of a guidance for industry on establishing pregnancy exposure registries. [Federal Register
Public Meeting. Meeting for Software Developers on the Common Formats for Patient Safety Data Collection and Event Reporting. April 25, 2014. Rockville, MD.
Convened by AHRQ, this meeting is designed as an interactive forum where Patient Safety Organizations (PSOs – formed under the Patient Safety and Quality Improvement Act) and software developers can provide input on the formats. AHRQ especially requests participation by and input from those entities which have used AHRQ's technical specifications and implemented, or plan to implement, the formats electronically. (Federal Register
Public Meeting on Patient-Focused Drug Development: Pulmonary Arterial Hypertension. May 13, 2014. FDA White Oak Campus, Silver Spring, MD.
Patient-Focused Drug Development is part of FDA’s performance commitments in the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patients’ perspectives on the impact of pulmonary arterial hypertension on daily life, as well as their perspectives on the available therapies for pulmonary arterial hypertension.
Symposium. 2014 Medical Countermeasures Initiative Regulatory Science Symposium. June 2-3, 2014. FDA White Oak Campus, Silver Spring, MD.
The symposium is intended to provide a forum for the exchange of scientific ideas for medical countermeasure development and evaluation, communicate progress on regulatory science efforts related to the development and advancement of medical countermeasures, facilitate innovative directions, and inform stakeholders on medical countermeasure-related scientific progress and accomplishments. [Federal Register
SECTION 4 OTHER REGULATORY AUTHORITIES & ORGANIZATIONS
CMS Supports HCV Screening for Baby Boomers
CMS issued a proposed decision memo
supporting coverage of screening for HCV infection in people at high risk for infection, as well as one-time screening in baby boomers -- the generation born between 1945-65. The U.S. Preventive Services Task Force (USPSTF) also backs HCV screening for the groups. Comments on CMS's decision memo are due April 3. The agency does not currently cover HCV screening (see BioCentury Extra, June 25, 2013
NIH adds substantial set of genetic, health information to online database
Researchers will now have access to genetic data linked to medical information on a diverse group of more than 78,000 people, enabling investigations into many diseases and conditions. The data, from one of the nation’s largest and most diverse genomics projects — Genetic Epidemiology Research on Aging (GERA) — have just been made available to qualified researchers through the database of Genotypes and Phenotypes (dbGaP), an online genetics database of the National Institutes of Health. The GERA cohort — average age 63 — was developed collaboratively by Kaiser Permanente and the University of California, San Francisco (UCSF).
In addition to diseases and conditions traditionally associated with aging, such as cardiovascular disease, cancer and osteoarthritis, researchers can explore the potential genetic underpinnings of a variety of diseases that affect people in adulthood, including depression, insomnia, diabetes, certain eye diseases and many others representing a variety of disease domains. Researchers will also be able to use the database to confirm or disprove other studies that use data from relatively small numbers of people, as well as to increase the size and power of their samples by adding participants from GERA to meta-analyses. The large cohort will also serve as a reference source of controls that researchers can compare to individuals with different conditions that they have studied. More at link above. (NIH)
NIH releases comprehensive new data outlining Hispanic/Latino health and habits
A comprehensive health and lifestyle analysis of people from a range of Hispanic/ Latino origins shows that this segment of the U.S. population is diverse, not only in ancestry, culture, and economic status, but also in the prevalence of several diseases, risk factors, and lifestyle habits.
These health data are derived from the Hispanic Community Health Study/Study of Latinos (HCHS/SOL), a landmark study that enrolled about 16,415 Hispanic/Latino adults living in San Diego, Chicago, Miami, and the Bronx, N.Y., who self-identified with Central American, Cuban, Dominican, Mexican, Puerto Rican, or South American origins. These new findings have been compiled and published as the Hispanic Community Health Study Data Book: A Report to the Communities.
The information contained in the HCHS/SOL data book will enable individuals, communities, scientists, and health policy makers to tailor health intervention strategies to improve the health of all Hispanics. More at link above. (NIH)
FDA and Drug Development for the Fatally Ill
Sharon Terry, an Ashoka Fellow, and Genetic Alliance have developed a platform that facilitates the responsible engagement of the FDA with severely ill patients, and they’re getting patients directly involved in voicing their concerns about the current system. The FDA’s initiative is called Patient-Focused Drug Development (PFDD), and it is designed to assess risks and benefits for specific patient communities. Genetic Alliance is crowdsourcing input for the FDA to hear from patients.
Terry’s initiative has recently been awarded a $1 million contract from the Patient Centered Outcomes Research Institute to be a part of the National Patient Centered Clinical Research Network. This news could mean big things ahead for patients with genetic diseases.
Terry hopes to increase the available pool of information—information about patients’ genetics and other personal data—to help accelerate discovery. She’d like to see a systemic solution across all diseases, rather than solutions that work on a case by case basis. To do that, she and her partners are putting in place a structure to empower disease groups and patients to vocalize their needs to the FDA and determine how and with whom their data is shared. More at link above. (Forbes)
Drug Developers Circumspect about Using Social Media in Clinical Research
Social media is gaining ground as an important tool to improve the clinical research process through more effective engagement of patient communities, but drug sponsors are proceeding cautiously, according to an analysis recently completed by the Tufts Center for the Study of Drug Development.
Nearly all drug sponsors have developed corporate policies to steer employee use of social media, but the lack of comprehensive, coordinated processes across most organizations has meant that the companies which are using social media in drug development are doing so in a siloed and experimental fashion, Tufts CSDD found.
Key concerns voiced by drug sponsors about using social media in clinical trials focus on violating patient privacy and confidentiality, jeopardizing research integrity, and influencing study volunteer receptivity to participating in clinical trials.
These and other findings from the new study were reported in the March/April Tufts CSDD Impact Report
, released March 6, 2014. More at link above. (Tufts CSDD)
USPTO updates guidance to determine eligibility of claims
The U.S. Patent and Trademark Office issued updated guidance to patent examiners on determining whether product claims that involve natural phenomena and natural products are patent eligible. The updated guidance notes these claims are patent eligible only if they are "significantly different" from what exists in nature. The guidance provides a list of factors that "weigh toward eligibility," including elements or steps that "impose meaningful limits on claim scope" or "add a feature that is more than well-understood, purely conventional or routine in the relevant field." The updated guidance also provides several examples for patent examiners, including when methods or process patent claims would be appropriate.
The new guidance replace preliminary guidance that PTO issued last June after the U.S. Supreme Court ruled in Association for Molecular Pathology, et al. v. U.S. PTO, et al
. that isolated DNA cannot be patented but cDNA can be patented. In the updated guidance, PTO said that "Myriad is a reminder that claims reciting or involving natural products should be examined for a marked difference" from the naturally occurring product (see BioCentury, June 17, 2013)
EMA Finalizes Guideline on Process Validation for Finished Products
The European Medicines Agency (EMA) stressed the potential benefits of continuous process validation in guidance issued this week and underlined that data submitted by drugmakers must demonstrate the adequacy of production operations at each site. This guideline replaces the previous note for guidance on process validation (CPMP/QWP/848/96, EMEA/CVMP/598/99). The guideline is brought into line with ICH Q8, Q9 and Q10 documents and the possibility to use continuous process verification in addition to, or instead of, traditional process validation described in the previous guideline has been added and is encouraged. This guideline does not introduce new requirements on medicinal products already authorised and on the market, but clarifies how companies can take advantage of the new possibilities given when applying enhanced process understanding coupled with risk management tools under an efficient quality system as described by ICH Q8, Q9 and Q10.
“Process validation should not be viewed as a one-off event. Process validation incorporates a lifecycle approach linking product and process development, validation of the commercial manufacturing process and maintenance of the process in a state of control during routine commercial production.” More at title link above. (EMA)
EMA, FDA extend Quality by Design pilot program
EMA and FDA agreed to extend by two years a pilot program for parallel assessment of Quality by Design (QbD) components of NDAs and MAAs. QbD is an approach using statistical, analytical and risk-management methodology in the design, development and manufacturing of medicines to ensure quality. One of the goals of the approach is to identify, explain and manage all sources of variability affecting a process. The EMA and FDA pilot program is intended to prevent the regulatory agencies from applying QbD standards inconsistently. The agencies reviewed one application for an undisclosed product from Pfizer Inc. and "several" scientific advice requests under the original three-year pilot program, which has run since April 2011. (BioCentury)
SECTION 5 LEGAL, POLICY, AND COMPLIANCE NEWS
What's New in the FDA 2015 Budget?
In a March 7 blog (FDA Voice), William Tootle, Director of FDA’s Office of Budget, commented on the proposed funding for FDA in President Obama’s FY 2015 Budget Message to Congress, indicating that the news is good. “The president is requesting a $4.7 billion budget for FDA, an 8.1 percent increase over the 2014 budget that Congress passed earlier this year.” Medical product safety, one of the three major budgetary categories along with food safety and medical countermeasures, is proposed to receive a $61 million increase, $25 million of which is allocated to strengthen oversight of the pharmacy compounding industry. Food safety would receive a $263 million increase ($253 million earmarked for implementation of the Food Safety Modernization Act) while medical countermeasures funding would remain stable at the 2014 levels. More at title link above. (FDA.gov)
Obama looks to shorten biologics exclusivity
President Obama has again proposed to shorten the exclusivity period for innovator biologics in his FY15 budget proposal. According to HHS's summary, the president's budget request includes a proposal to cut the exclusivity period to seven years from the current 12 years. Obama proposed the same change in his FY14 budget request.
Among other measures in the president's FY15 budget plan that could affect biotech and pharma, Obama is proposing to authorize the Federal Trade Commission to prohibit pay-for-delay deals between branded and generic companies starting in 2015, which would save an estimated $9.1 billion for Medicare over 10 years. More at title link above. (BioCentury)
CMS: Uncommon Alliance of Stakeholders Push Back on Controversial Proposals to Change Medicare Part D
The House Committee on Energy and Commerce, Subcommittee on Health held a hearing on February 26 entitled "Messing with Success: How CMS' Attack on the Part D Program Will Increase Costs and Reduce Choices for Seniors." The focus was on a proposed rule that would make cost-saving changes to Part D of Medicare, which provides private insurance for prescription drugs to approximately 40 million elderly and disabled Medicare beneficiaries.
While government officials claim that the program in its current form has saved $8.9 billion on prescription drug costs for Medicare recipients, CMS proclaims that the proposed rule, if finalized, would save an additional $1.3 billion over five years, 2015 – 2019. The most controversial changes to Part D are a reduction of protected drug classes (antidepressants and immunosuppressant drugs would no longer be protected), elimination of preferred pharmacy networks, and limiting plan options.
Critics, which include patient advocacy groups, industry representatives, independent pharmacies, and others, fear the proposed changes could leave some beneficiaries without coverage for needed drugs and generally with fewer choices overall. More at link above. (Policy and Medicine)
SECTION 6 SOURCES REVIEWED FOR THIS NEWSLETTER
A partial listing of sources reviewed for this newsletter:
AdvaMed Smartbrief; AHRQ Newsletter; Alzheimers Association; Alzheimers Research Forum Newsletter; BioCentury; Biopharma Reporter; BIOtechNow; CDISC Monthly Newsletter; CER Daily Newsfeed (NPC); Daily Dose (Becker); DIA Daily; Drug Daily Bulletin; EMA website; EP Vantage; Evaluate Pharma; Eye on FDA; FDA.gov; FDA Law Blog; Federal Register Table of Contents; Fierce Medical Devices; Fierce Pharma; Fierce Vaccines; FDLI Smartbrief; Genomeweb; Health Industry Washington Watch; Government Health IT; Health IT Security; Institute of Medicine News; MedCityNews; Medical Device Daily; Medical Device & Diagnostic Industry; MedPage Today; NPC Bulletin; Nutra Ingredients USA; Pharmabiz; Pharmafile; Pharma IQ; PharmaTimes; PhRMA website; PM Live; Policy and Medicine (newsletter); Regulatory Focus; RegLink News; US FDA Daily Digest Bulletin.