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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: January 23, 2015

SECTION 1 FDA GUIDANCES & MAPPS

CDER 2015 Plan for New & Revised Guidances
The link above is the new CDER list of guidances planned for new issue or revision in Calendar Year 2015.

Searchable Database of All Official FDA Guidance Documents and Other Regulatory Guidance
FDA has created a database that provides a convenient way y to search for all FDA guidance documents from a single location. You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period. Access the database at the link above. (FDA.gov)

CDRH FY 2015 Proposed Guidance & Focused Retrospective Finalized Guidance
The lists below include guidance documents that CDRH intends to publish this fiscal year (FY2015) as well as previously-issued final guidances for which CDRH would appreciate external feedback on whether these final guidances should be revised or withdrawn. We have provided three lists: (1) a list of guidance documents that the Agency fully intends to publish (the “A-list”); (2) a list of guidance documents that the Agency intends to publish as resources permit (the “B-list”); and (3) a list of final guidance documents that issued in 2005, 1995, and 1985 subject to focused retrospective review. Although resource constraints and new issues that emerge over the course of the year may preclude CDRH from issuing every guidance document on the A-list and B-list and may require that CDRH issue guidance documents not on the lists, the A-list and B-list are intended to provide helpful information about CDRH’s current priorities for the upcoming fiscal year. CDRH plans to update all three lists every year.  (FDA.gov)

On January 11, 2015, FDA announced the availability of a draft guidance entitled “Evaluating Drug Effects on the Ability To Operate a Motor Vehicle.”  The purpose of this guidance is to assist sponsors in the evaluation of the effects of psychoactive drugs on the ability to operate a motor vehicle. Reducing the incidence of motor vehicle accidents (MVAs) that occur because of drug impaired driving is a public health priority. This draft guidance recommends using a systematic effort to identify drugs that increase the risk of MVAs as a critical component of assessing drug risk and designing strategies to reduce this risk.  Comments should be submitted by March 17, 2015.  [Federal Register]

On January 20, 2015, FDA announced the availability of the draft guidance entitled ‘‘General Wellness: Policy for Low Risk Devices.” FDA is issuing this draft guidance to provide clarity to industry and FDA staff on CDRH’s compliance policy for low-risk products that promote a healthy lifestyle (general wellness products). CDRH does not intend to examine low-risk general wellness products, as discussed in this guidance, to determine whether they are devices within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321(h)), or, if they are devices, whether they comply with the FD&C Act’s regulatory requirements for devices. For purposes of the guidance, CDRH defines ‘‘general wellness products’’ as products which meet the following factors: (1) Are intended for only general wellness use, as defined in this guidance and (2) present a very low risk to users’ safety. General wellness products can include exercise equipment, audio recordings, mobile apps, video games, and other products that are typically available from retail establishments (including online retailers and distributors that offer mobile apps to be directly downloaded), when consistent with the two factors above. Comments should be submitted by April 20, 2015. [Federal Register]

On January 20, 2015, FDA announced the availability of the draft guidance entitled ‘‘Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types.” This draft document provides proposed guidance to industry and FDA staff about the regulation of accessories in medical devices. The guidance explains what FDA considers to be an ‘‘accessory,’’ outlines how the risk- based framework for the classification of devices applies to accessories, and describes the use of the de novo classification process for the classification of new types of accessories. Comments should be submitted by April 20, 2015. [Federal Register]

On January 20, 2015, FDA announced the availability of the draft guidance entitled ‘‘Mitigating the Risk of Cross-Contamination From Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes.” This draft guidance document, when finalized, will highlight the cross- contamination risk associated with specific types of irrigation valves and accessories when used with flexible gastrointestinal endoscopes, clarify terminology used to describe these devices, and outline strategies to mitigate the risk of cross-contamination between patients. Comments should be submitted by April 20, 2015. [Federal Register]

On January 21, 2015, FDA announced the opportunity for public comment on the collection of information proposed to OMB, regarding the ‘‘Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products.” FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. The Federal Register notice describes the content and format for labeling proposed by FDA; comments should be submitted by March 23, 2015. [Federal Register]

On January 23, 2015, FDA announced the opportunity for public comment on the proposed collection of information regarding the ‘‘Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application.” This guidance document provides recommendations on postmarketing serious adverse event reporting for nonprescription (over-the- counter) human drugs marketed without an approved application. It provides recommendations on the minimum data elements that should be included in a serious adverse event report, the label that should be included with the report, reporting formats for paper and electronic submissions, and how and where to submit the reports. Comments should be submitted by March 24, 2015. [Federal Register]

On January 23, 2015, FDA announced a ‘‘Request for Nominations for Voting Members on a Public Advisory Committee; Science Board to the Food and Drug Administration.” (FDA) is requesting nominations for members to serve on the Science Board to the Food and Drug Administration, Office of the Commissioner, Office of the Chief Scientist. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups. Nominations should be submitted by March 24, 2015. [Federal Register]


SECTION 2 FDA NOTES & RELATED NEWS

FDA Novel New Drugs 2014: Summary Report
It was another another strong year in 2014 for FDA approval of novel new drugs for patients in need, with the approval of 41 novel drugs, the most in nearly 20 years. Many of the 41 new drugs have the potential to add significant clinical value to the care of thousands of patients with serious or life-threatening diseases. They include eight new drugs for treating patients with various types of cancer, four new drugs to treat type-2 diabetes, four new antibiotics to treat serious infections, and two new products to treat patients with hepatitis C.

Seventeen (41%) of the 41 novel new drugs were approved to treat rare diseases that affect 200,000 or fewer Americans. This is the highest yearly total of such drugs ever — surpassing the previous high of 13 from 2012. These approvals are particularly significant because patients with rare diseases often have few or no drugs available to treat their conditions.

Seventeen (41%) of the 41 novel new drugs are identified by CDER as “First-in-Class,” one indicator of a drug’s degree of innovation. The total for First-In-Class approvals in 2014 approaches the highest yearly total of 20 reported in 2012.  More at link above.  (FDA.gov)

CDRH Update to Strategic Priorities
CDRH has released an update of its strategic priorities for the year 2015 (see link above for report).  The forward to the report:  

“The Center for Devices and Radiological Health's (CDRH) 2014-2015 Strategic Priorities describe the most important areas we are focusing on because they are critical to achieving our vision – that patients in U.S. have access to high-quality, safe and effective medical devices of public health importance first in the world. Our strategic priorities are: strengthen the clinical trial enterprise; strike the right balance between premarket and post market data collection; and provide excellent customer service. We hold ourselves accountable for implementing our priorities by achieving measurable outcomes and reporting our performance to the public.” More at link above. (FDA.gov)

FDA Invites Participating in MDSAP Pilot
The  MDSAP  Regulatory  Authority  Council  (RAC)  is  pleased  to  announce  that  medical  device manufacturers are now invited to participate in the MDSAP Pilot. The participants in the process during the pilot will help shape the policies and procedures for the operational program scheduled to begin in 2017.

The MDSAP Pilot, which started on January 1, 2014, is an implementation of the MDSAP initiative based on the foundational work of the International Medical Device Regulators Forum (IMDRF).

The MDSAP Pilot enables medical device manufacturers to have an authorized Auditing Organization under the MDSAP Pilot conduct a single audit of a medical device manufacturer that will satisfy the relevant requirements of those medical device regulatory authorities participating in the pilot program. MDSAP Pilot audit reports may be used by regulatory authorities participating in the MDSAP Pilot in lieu of their own inspection reports.  The international partners for the MDSAP Pilot are: the Australian Therapeutic Goods Administration (TGA), the Brazilian National Health Surveillance Agency (ANVISA), Health Canada, and the U.S. Food and Drug Administration (FDA).  Japan’s Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) are observers.  More at link above.

Also posted by FDA: Q&A on the MDSAP  (FDA.gov)

FDA Panel to Review Compounding Revisions
FDA's Pharmacy Compounding Advisory Committee (PCAC) will meet on Feb. 23-24 to discuss proposed revisions to the agency's lists of bulk substances that may or may not be compounded under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.

PCAC will discuss comments received on FDA's notice of proposed rulemaking that seeks to add 25 drug products to the list that cannot be compounded based on new data indicating they are unsafe or ineffective.

The committee will also discuss six bulk substances that have been nominated for inclusion on the list that can be compounded and will consider proposed criteria for further developing the list.  (BioCentury)


SECTION 3 AGENCY AND ADVISORY COMMITTEE MEETINGS

Patient-Focused Drug Development: Disease Area Meetings Planned for FY2013-2015

Public Standards Committee Meeting. Health Information Technology Standards Committee Advisory Meeting.  Monthly beginning January 28, 2015.  Locations to be published.  This notice announces forthcoming meetings of a public advisory committee of the Office of the National Coordinator for Health Information Technology (ONC). The function of the committee is to provide recommendations to the National Coordinator on standards, implementation specifications, and certification criteria for the electronic exchange and use of health information for purposes of adoption, consistent with the implementation of the Federal Health IT Strategic Plan, and in accordance with policies developed by the Health IT Policy Committee. [Federal Register]

Public Workshop. Seventh Annual Sentinel Initiative. February 5, 2015.  Washington, DC.  Convened by the Engelberg Center for Health Care Reform at the Brookings Institution and supported by a cooperative agreement with FDA, this 1-day workshop will bring the stakeholder community together to discuss a variety of topics on active medical product surveillance. There will also be a live webcast for those unable to attend the meeting in person. [Federal Register]

Public Workshop. Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests.  February 20, 2015.  Natcher Center at the National Institutes of Health Campus, Bethesda, MD.  The purpose of this workshop is to discuss and receive feedback from the community on the questions in the discussion paper on diagnostic tests for human genetics or genomics using next generation sequencing (NGS) technology. [Federal Register]

Public Advisory Committee Meeting. Science Board to the Food and Drug Administration. March 4, 2015.  White Oak Campus, Silver Spring, MD.  Among other agenda items, the Science Board will be provided with a progress or final draft report the Commissioner’s Fellowship Program Evaluation subcommittee and will hear a progress report from Science Moving Forward subcommittee. The Science Board will be asked to provide feedback on FDA’s public access policy. FDA will seek the Science Board’s input regarding approaches to regulatory science training coordination. [Federal Register]

Public Advisory Committee Meeting. Vaccines and Related Biological Products. March 4, 2015.  Silver Spring, MD.  The committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2015–2016 influenza season.  [Federal Register]

Public Conference. Serious Drug-Induced Liver Injury: The Importance of Getting It Right: How To Measure and Interpret Drug-Induced Liver Injury Information and Make Correct Diagnoses.  March 18-19, 2015.  Hyattsville, MD.  The purpose of the public conference 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 Meeting. Patient-Focused Drug Development for Breast Cancer. April 2, 2015.  White Oak Campus, Silver Spring, MD.  The public meeting is intended to allow FDA to obtain patient perspectives on the impact of breast cancer on daily life and patient views on treatment approaches. [Federal Register]

Public Meeting. Chagas Disease Patient-Focused Drug Development. April 28, 2015.  White Oak Campus, Silver Spring, MD.  FDA is interested in obtaining patient input on the impact of Chagas disease on daily life and patients’ views on currently available therapies to treat the condition. [FDA.gov]


SECTION 4 OTHER REGULATORY AUTHORITIES & ORGANIZATIONS

US Developing Large Scale Genomics Project
The Obama administration is planning a new, large-scale genomics project that could be formally announced in the State of the Union speech on Tuesday, according to administration sources. NIH Director Francis Collins proposed the project to the White House. NIH will lead the project, which will include FDA and other federal agencies.

The project will include sequencing of up to a million human genomes. It will incorporate a push to develop new tools to analyze large genomics databases and make the data useful for research and medicine.  (BioCentury)

CMS Chief Administrator Marilyn Tavenner Will Resign in February
CMS Administrator Marilyn Tavenner announced Friday that she will be leaving the CMS at the end of February. Her replacement, at least temporarily, will be Andy Slavitt, formerly a UnitedHealth Group executive who is now principal deputy administrator. Tavenner, 63, spent more than three years in the post.

Speculation will now turn to whom President Barack Obama might nominate to replace Tavenner and if any nominee can gain approval from the Republican-controlled Senate.


“I think it's going to be very hard to get someone confirmed into this role,” said Dr. Scott Gottlieb, a scholar with the American Enterprise Institute, a conservative think tank. “I wouldn't be surprised to see someone act in the role for a prolonged period and then be appointed for the final year during a recess.” More at link above. (Modern Healthcare)

ACCME Names Graham T. McMahon, MD, MMSc, as New President and CEO Beginning April 2015
The Accreditation Council for Continuing Medical Education (ACCME) Board of Directors announced on January 12, 2015, that it has chosen Graham T. McMahon, MD, MMSc, as the new President and CEO. The Board chose Dr. McMahon unanimously, and he will begin his tenure in April 2015, following the retirement of Murray Kopelow, MD, the current President and CEO of ACCME.

According to the ACCME Press Release, Dr. Kopelow will continue to lead the ACCME during the transition period and will work with the Board of Directors and Dr. McMahon until July 31, 2015, to ensure a smooth leadership transition process.

“At the time of his retirement, Dr. Kopelow will have completed more than 30 years of exemplary service to the CME community, with 20 of those years spent as the ACCME’s Chief Executive,” ACCME states. “He leaves the ACCME in a healthy financial position, with an energetic, creative, and dedicated staff. During his tenure, the ACCME and accredited continuing medical education have grown in stature, importance, and relevance.”  

ASCO Expects CancerLinQ to go Live in 2015
The American Society of Clinical Oncology said Tuesday that SAP SE will provide computing infrastructure for the organization's CancerLinQ learning health system, with a launch expected this year.

CancerLinQ will use SAP's software to collect, aggregate and analyze data from electronic health records and oncology practice management systems that serve millions of patients, according to ASCO. The system is intended to provide real-time clinical decision support to physicians by informing them about evidence-based practice guidelines, as well as clinical experiences and outcomes of patients that closely match the patient being treated. CancerLinQ's data may also be used to revise practice guidelines.

ASCO said eight U.S. oncology practices have agreed to provide patient records for the first version of CancerLinQ and seven large cancer centers will soon sign on, "meaning approximately 500,000 patients will be represented in the first version of CancerLinQ." (BioCentury)

Boutin Becomes CEO of National Health Council
The National Health Council (NHC) said EVP and COO Marc Boutin will succeed Myrl Weinberg as CEO, effective March 1. Weinberg announced her intention last June to step down as head of the umbrella organization for more than 100 patient advocacy organizations, professional organizations and healthcare industry members focused on chronic diseases and disabilities.
Boutin serves on the International Alliance of Patients' Organizations governing board and is its treasurer. He is a member of the Community Health Charities board, the Patient-Centered Outcomes Research Institute (PCORI) Advisory Panel on Patient Engagement and the Drug Information Association's North America advisory board.  (BioCentury)

Industry Involvement in Medical Education: Debunking the Myth
A recent article by Harry Pellman, M.D. entitled The importance of bias in education dispels some of the myths about pharmaceutical company involvement in physician education. With 22 years of chairing the CME Committee of an active American Academy of Pediatrics (AAP) Chapter and co-chairing the CME Committee of an AAP District, Pellman notes that he's had "intimate interactions with hundreds of nationally recognized speakers, some with and some without industry affiliation." He writes: "Myths, frequently perpetuated by those with little or no real-world contact with these programs or by people with anti-industry bias and peppered with words like 'perceived' and 'potential conflict,' need to be corrected."

How are these myths started and in many cases perpetuated? Pellman looks to a comprehensive journal review regarding industry-academic relationships in four influential journals published over the last few decades.  

Of the 108 published articles the study looked at, only 12 were either neutral or emphasized some benefit. Of these 12, all addressed the opposing points of view, and 50% critically emphasized and attempted to refute the alternative points of view. On the other hand, however, 16 research articles (15%) emphasized the risks of a relationship with industry, and none critically analyzed and attempted to refute the alternative points of view. The majority, 80 (74%) were commentary articles that emphasized the risks of a relationship with industry, and only 7 articles critically analyzed and attempted to refute the opposing points of view.

"The authors conclude that a major anti-industry publication bias exists and that a conformity cascade – where policy does not emerge from objective weighing of evidence but from social pressure – may be a factor for this major bias from medical journals that are influential in affecting policy," Pellman writes.  More at link above. (Policy and Medicine)

National Bureau of Economic Research Releases Paper on Pricing of Anticancer Drugs
A new paper published by the National Bureau of Economic Research finds that, of 58 cancer drugs that were approved by the FDA between 1995 and 2013, the launch prices increased by 10% a year, or an average of about $8,500, when adjusted for inflation and a formula for determining survival benefits.

The authors offer various reasons as to why prices have climbed. They point to “generous” insurance coverage that “insulates patients from drug prices, strong financial incentives for physicians and hospitals to use novel products and the lack of therapeutic substitutes.”

They also maintain that, even though physicians “may be reluctant to prescribe medicines with prices that exceed subjective standards of fairness,” doctors can also become “habituated to rising prices,” which gives drug makers the “leeway to set even higher prices in the future.” More at link above.  (NBER via WSJ Pharmalot)

First Innovative Medicines Initiative Ebola Projects Get Underway
The Innovative Medicines Initiative (IMI) is launching the first eight projects of its Ebola+ programme, to accelerate all aspects of vaccine development and manufacturing as well as deployment and compliance with vaccine regimens and diagnostics. The announcement comes in the run up to the World Economic Forum in Davos, where Ebola will feature high on the agenda.

The eight projects were selected from proposals submitted under IMI’s first Ebola+ Call for proposals, which was launched in November 2014. The Ebola+ programme was created in response to the ongoing Ebola outbreak in western Africa, which has killed over 8 000 people so far. Between them, the projects bring together over 40 partners from the pharmaceutical & diagnostics industries, public health bodies, academia, aid organizations, and small biotech companies in Europe, Africa and the United States. Previous experience at IMI has shown that consortia of this kind, bringing together diverse groups from around the world, can make progress in even the most challenging disease areas.

The projects will have a total budget of €215 million, part of which comes from Horizon 2020, the EU’s research and innovation programme, and part of which comes in the form of in-kind contributions from the European Federation of Pharmaceutical Industries and Associations (EFPIA) partners in the projects.  More at link above. (IMI)

Europe to boost international cooperation on generics
The European Medicines Agency (EMA) is ready to share its assessments of applications for generic medicines in real time with collaborating regulatory agencies outside the European Union (EU). This initiative aims to facilitate the timely authorisation and availability of safe, effective and high quality generic medicines worldwide. The first phase of the pilot project will involve the EU, Australia, Canada, Chinese Taipei and Switzerland.

The information-sharing initiative is part of the International Generic Drug Regulators Pilot (IGDRP). It started in July 2014 using the European Union decentralised procedure as a model, and it is now extended to the centralized procedure.

The EU is leading this initiative with the aim to both save global assessment resources and to facilitate and strengthen the scientific assessment process for medicines. It is expected that this sharing of assessments will allow authorisation of generic products in concerned countries in a coordinated and resource effective way.  More at title link above.   (EMA.europa.eu)

Public consultation on application of transparency rules of EU Clinical Trial Regulation
The public consultation on how the transparency rules of the European Clinical Trial Regulation will be applied in the new clinical trial database is launched by the European Medicines Agency (EMA) today (January 21, 2015).

The European Clinical Trial Regulation aims to create an environment that is favourable to conducting clinical trials in the European Union (EU), with the highest standards of safety for participants. The Regulation ensures that the rules for conducting clinical trials are consistent throughout the EU. It also transforms the level of information publicly available for each clinical trial carried out in the EU by requiring transparency on the authorisation, conduct, and results of the trial. The Regulation will apply to clinical trials that are registered once the Regulation is in operation (not before 28 May 2016).

The document under consultation sets out proposals for the application of the transparency rules of the European Clinical Trial Regulation for stakeholders to review and comment on. The proposals aim to balance the right of patients and the public to access extensive and timely information on clinical trials, and developers’ and researchers’ need to benefit from investments. This will support the EU as a suitable location for innovative, cutting-edge research and development of medicines.

Stakeholders are invited to send comments using this template to CTReg@ema.europa.eu by close of business on 18 February 2015. More at title link above.  (EMA.europa.eu)

New international standard to improve safety of medicines
The European Medicines Agency (EMA) has published a guide to support the implementation of a new international standard for the safety monitoring of medicines in the European Union (EU). The so-called ISO ICSR standard improves the reporting of suspected side effects of medicines in Individual Case Safety Reports (ICSRs). The use of the new international standard will take effect on 1 July 2016.

ISO ICSR aims to establish the same format for the reports on individual cases of suspected side effects in patients due to a medicine across the world. It also is expected to include better information on medicines that might be associated with an adverse drug reaction and on the therapeutic uses of those medicines. In addition, the standard also strengthens personal data protection in the records of ICSRs collected by pharmaceutical companies and regulatory authorities.

The finalization of the guide is a major step in EMA’s preparation for an enhanced EudraVigilance system, the European database of all suspected adverse reactions reported with medicines authorised in the European Economic Area (EEA), as required by the EU pharmacovigilance legislation.  More at link above.  (EMA.europa.eu)

Global Health Impact Report Ranks Pharmas on Antibiotics Efforts
The Global Health Impact Index measures three factors: the need for several important drugs for three specific infectious diseases: tuberculosis, HIV/AIDS and malaria; the effectiveness of the available treatments; and the number of people who can access those drugs. The rankings estimate the amount of death and disability the drugs are alleviating.

While there may be sufficient data available to track the need for such medicines, there is currently no way to determine the extent to which drug makers and their products are having a desired effect, according to Nicole Hassoun, an associate philosophy professor at Binghamton University, who developed the index.

“By better understanding the impacts of products on the burden of disease, the index gives researchers a tool for measuring impact, governments and donors can better target their efforts and companies can be incentivized to focus on impact,” she writes.

There is another tool called the Access to Medicines Index, which assesses such factors as patenting policies, price reductions, involvement in public-private partnerships and chari¬table contributions.  More at link above.  (Via Pharmalot)


SECTION 5 LEGAL AND COMPLIANCE

Hatch, Bipartisan Group of Senators Announce Legislation to End Tax on Medical Device Manufacturers
A bipartisan group of ten Senators, led by Senate Finance Committee Chairman Orrin Hatch (R-Utah), today introduced the Medical Device Access and Innovation Protection Act, S. 149, a bill to repeal the medical device tax that was implemented as a part of the Patient Protection and Affordable Care Act (PPACA). Under PPACA, manufacturers of medical devices are required to pay a 2.3 percent excise tax on products ranging from surgical tools to bed pans.

Members of the medical device community reiterated their support for repeal in a letter today signed by nearly 1,000 corporations and associations.

Joining Hatch in introducing the Medical Device Access and Innovation Protection Act today were Sens. Amy Klobuchar (D-Minn.), Pat Toomey (R-Pa.), Joe Donnelly (D-Ind.),  Richard Burr (R-N.C.), Al Franken (D-Minn.), Rob Portman (R-Ohio), Bob Casey (D-Pa.), Dan Coats (R-Ind.), and Jeanne Shaheen (D-N.H.). More at link above. (USS Committee on Finance News Release)

SCOTUS Leaves Generic Labeling Rules to FDA
The U.S. Supreme Court declined to review a petition from Teva Pharmaceutical Industries Ltd. and the Caraco Pharmaceutical Laboratories Ltd. subsidiary of Sun Pharmaceutical Industries Ltd. asking the high court to affirm federal jurisdiction over state tort actions involving label changes for generic drugs.

The petition asked SCOTUS to review a California Court of Appeal ruling in a case that allowed the plaintiff, Olga Pikerie, to pursue claims for injuries after use of generic osteoporosis drug sodium alendronate. Pikerie's suit charged that Teva, Caraco and other companies failed to update the labels of their generic versions of Fosamax alendronate to match changes made to the label of the branded version by Merck & Co. Inc., which referred to risks of femoral shaft fractures. According to Teva and Caraco, the California court erred in allowing state tort claims to preempt federal law.

In November 2013, FDA proposed a rule that would allow generic manufacturers to change a label independent of the reference brand drug, which could open the door for generics companies to be held liable for failure to provide adequate warnings. Under the proposed rule, an ANDA holder would be able to update product labeling to reflect newly acquired safety information before FDA reviews the changes. Generic manufacturers would be required to notify both FDA and the brand name manufacturer of the change. The final rule is slated to be published Sept. 30, 2015.  (BioCentury)

Obama Proposes Precision Medicine and Antibiotics Initiatives
In Tuesday's State of the Union address, President Obama announced the launch of a "new Precision Medicine Initiative to bring us closer to curing diseases like cancer and diabetes -- and to give all of us access to the personalized information we need to keep ourselves and our families healthier."

A White House statement added few details, noting that "advances in genomics and digital data have produced powerful new discoveries about health and disease that have made it possible to design highly effective, targeted treatments for cancer and other diseases. The President's proposal will engage patients and healthcare providers in delivering this new era of medicine."

Obama is also proposing increased funding for antibiotic discovery research. "To help address the global threat of infectious disease created by rampant spread of antibiotic-resistant bacteria, the President also proposes to nearly double the Federal investment in antibiotic discovery," according to the White House statement. NIH's National Institute for Allergy and Infectious Diseases invested $163 million in FY13 to study antimicrobial resistance, not including HIV.

Details of the precision medicine and antibiotic initiatives, including costs and information about whether they will require additional appropriations, are expected on or before the Feb. 2 release of the Obama administration's FY16 budget request. More at link above. (BioCentury)

Bipartisan House Bill Introduced to Exclude Educational Materials from Sunshine Act Reporting
Congressmen Michael C. Burgess, M.D. (R-TX), Chairman of the House Energy and Commerce Subcommittee on Commerce, Manufacturing and Trade, and Peter DeFazio (D-OR) t introduced bipartisan legislation to allow physicians full access to the most up-to-date educational materials like textbooks and journals so they may deliver the best care.

The Protect Continuing Physician Education and Patient Care Act, H.R. 293, is in response to the Physician Payment Sunshine Act’s unintended consequence of over-burdensome reporting requirements that made access to educational materials for physicians difficult to obtain.

The Sunshine Act was intended to make payments to physicians more transparent. The bill, which was a part of the Affordable Care Act, included 12 specific exclusions from the reporting requirement in order to ensure that medical practices and patient care would not be harmed. But in recent rules, the Centers for Medicare and Medicaid Services (CMS) determined that both continuing medical education events and the distribution of medical textbooks and peer-reviewed journals were subject to reporting, making them less accessible to physicians.

This bill will minimize the negative impacts of the Sunshine Act by making these important materials exempt from reporting requirements. (Press release)

Senator Wants Big Drug Makers that Break the Law to Fund NIH
Seeking to replenish funding for new scientific research, U.S. Sen. Elizabeth Warren (D-Ma.) plans to introduce a bill next week that would require drug makers that break the law to send some of their profits to the U.S. National Institutes of Health.

Drug makers that reach settlements with the federal government for paying kickbacks to doctors, defrauding Medicare or Medicaid or illegally marketing medicines would have to pay 1% of their annual profits for each blockbuster medicine that can be traced to public sector research. Such a penalty would run for five years, which Warren notes is the same amount of time covered under most settlements.  More at link above.  (WSJ Pharmalot)


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.