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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: November 14, 2014

SECTION 1 FDA GUIDANCES & MAPPS

CDER List of Guidance Documents (Updated)

CDER Guidances New/Revised/Withdrawn 1/1/14 - 9/30/14

The links above lead to the List of Guidance Documents (CDER) updated on October 27, 2014, and to CDER Guidances that are new, revised, or withdrawn through the third calendar quarter of 2014.

Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2014 (PDF - 31KB)

CDRH FY 2014 Proposed Guidance Development

On November 6, 2014, FDA announced the availability of a Manual of Policies and Procedures (MAPP) for the CDER Office of Translational Sciences entitled ‘‘Critical Path Innovation Meetings Policy and Procedures.’’ (MAPP 7700.5) The purpose of this MAPP is to delineate the roles and responsibilities of CDER staff and the procedures to be followed for the Critical Path Innovation Meeting (CPIM). The CPIM is a nonbinding scientific dialog between FDA and investigators from industry, academia, patient advocacy groups, and government to explore novel ideas with the potential to augment drug development and advance regulatory science and policy. The CPIM is intended to be a general discussion of challenges in drug development and innovative strategies to address them. The discussion is not specific to any particular medical product. The scope of the CPIM includes biomarkers in early phase development, clinical outcome assessments in early phase development, natural history study designs and implementation, emerging technologies or new uses of existing technologies, and innovative conceptual approaches to clinical trial design and analysis. [FDA.gov]

On November 12, 2014, FDA announced the availability of a guidance entitled ‘‘Combined Functionality for Molecular Diagnostic Instruments.” This guidance document provides industry and Agency staff with FDA’s current thinking on regulation of molecular diagnostic instruments that combine in a single instrument both approved/ cleared device functions and device functions for which approval/clearance is not required, and on the type of information that FDA recommends that applicants include in a submission for a molecular diagnostic instrument that measures or characterizes nucleic acid analytes and has combined functions. The recommendations in this guidance do not apply to assays and reagents. They are also not intended to change FDA’s position regarding the marketing of Research Use Only and Investigational Use Only assays for clinical use. [Federal Register]

On November 12, 2014, FDA announced the opportunity for public comment on proposed research entitled “Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in DTC Prescription Drug Ads.” This project will examine the effects of variation in ad exposure frequency on perception and mental processing of risk and benefit information in direct-to-consumer (DTC) prescription drug ads.  Comments should be submitted by January 12, 2015.  FDA will seek clearance from OMB to conduct the study.  [Federal Register]

On November 12, FDA announced the proposal of an administrative order for “Orthopedic Devices; Reclassification of Thoracolumbosacral Rigid Pedicle Screw Systems; Classification and Effective Date of Requirement for Premarket Approval for Dynamic Stabilization Systems.”  FDA is proposing in this administrative order to reclassify rigid pedicle screw systems, a preamendments class III device, into class II (special controls); require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the dynamic stabilization systems, currently a subtype of pedicle screws, regardless of the indication for use; and clarify the device identification of pedicle screw spinal systems, to more clearly delineate between rigid pedicle screw systems and dynamic stabilization systems.  Comments should be submitted by February 10, 2015. [Federal Register]

On November 14, 2014, FDA announced the opportunity for public comment on proposed collection of information on “Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements.” This notice solicits comments on the information collection in the regulations on the Prescription Drug Marketing Act of 1987; Administrative Procedures, Policies, and Requirements. PDMA was intended to ensure that drug products purchased by consumers are safe and effective and to avoid an unacceptable risk that counterfeit, adulterated, misbranded, subpotent, or expired drugs are sold. FDA is requesting OMB approval for the existing reporting and recordkeeping requirements (listed in FR Notice).  [Federal Register]

On November 17, 2014, FDA announced the availability of a draft guidance entitled ‘‘Rare Pediatric Disease Priority Review Vouchers.’’  FDA will award priority review vouchers to sponsors of certain rare pediatric disease product applications that meet the criteria specified in that section. These vouchers can be used when submitting future human drug marketing applications that would not otherwise qualify for priority review. These vouchers can be sold or transferred for use to another sponsor any number of times before the voucher is used, as long as the sponsor making the transfer has not yet submitted the application. Because there exists a need for products for rare pediatric diseases, this program is intended to encourage development of new drug and biological products for prevention and treatment of certain rare pediatric diseases.  Comments should be submitted by January 16, 2015.  [Federal Register]

On November 17, 2014, FDA announced a correction to the proposed rule entitled “Additions and Modifications to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness.” The document proposed amending FDA’s regulations to revise the list of drug products that may not be compounded under the exemptions provided by the Federal Food, Drug, and Cosmetic Act because the drug products have been withdrawn or removed from the market after the drug products or components of such drug products were found to be unsafe or not effective. The document also withdrew the previous proposed rule regarding additions to this list (see the Federal Register of January 4, 2000). The document was published with an incorrect RIN number. This document corrects the error. [Federal Register]


SECTION 2 FDA NOTES & RELATED NEWS

Updated List of CDER Key Officials Posted

FDA's Gutierrez clarifies LDT review timelines
Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health (OIR) at FDA's Center for Devices and Radiological Health (CDRH), clarified the agency's timelines as it institutes a regulatory approach for laboratory-developed tests. Gutierrez shared with BioCentury his recent presentation at the Clinical Laboratory Improvement Advisory Committee (CLIAC) meeting in Atlanta and discussed details of the agency's approach, outlined in draft guidance released in September.  

Gutierrez said that new LDTs in the highest-risk category will be required to undergo premarket review as soon as the agency's final guidance takes effect. Manufacturers of already-marketed LDTs in the highest-risk category will have six months to notify the agency and begin adverse event reporting, and 12 months to submit applications for review.

Highest-risk LDTs include those with the same intended use as approved companion diagnostics, those with the same intended use as approved Class III medical devices, and some LDTs that help determine safety and efficacy of blood or blood products.

Two years after adoption of the final guidance, FDA intends to publish a prioritized list of the remaining high-risk LDT categories. It plans to review top-priority high-risk LDTs in year three, and the remainder by year five. Top-priority high-risk LDTs include devices that act like companion diagnostics, diagnostics for some infectious diseases with high-risk intended uses, and screening devices that will be the only confirmation of serious conditions in asymptomatic patients.

FDA intends to publish its list of moderate-risk LDTs four years after the guidance's adoption, and conduct reviews of them by year nine. More at link above. (BioCentury)

Duchenne Muscular Dystrophy Statement
On October 30, 2014, FDA posted a statement regarding the October 27, 2014 Sarepta Therapeutics statement about its planned NDA for eteplirsen to treat patients with Duchenne muscular dystrophy (DMD).  It begins:

“FDA recognizes the unmet medical need in Duchenne muscular dystrophy (DMD), the devastating nature of the disease for patients and their families, and the urgency to make new treatments available.  We remain committed to working with all companies to expedite the development and approval of safe and effective drugs to treat this disease.”

The FDA statement details the history of its work with the company to bring along the development of the drug and indicates that it is willing to conduct a rolling review of Sarepta’s NDA, that the NDA is expected to qualify for a priority review, and that a public advisory committee meeting will be held before FDA makes a decision on approval. The public advisory committee meeting will “afford FDA the ability to gain advice from outside experts and interested stakeholders on the adequacy of the data to support approval, including the possibility of “accelerated approval” – a mechanism to approve drugs in particular situations prior to the availability of definitive evidence of effectiveness.”

FDA closes its statement with the following:  “FDA understands the dire urgency of the situation and the importance of our actions to the DMD community.  FDA will continue to work with Sarepta in their efforts to provide the data it considers critical to FDA’s ability to review the NDA and reach a decision on approvability.”  More at link above. (FDA.gov)


SECTION 3 AGENCY AND ADVISORY COMMITTEE MEETINGS

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

FDA Outreach Meeting.  FDA Outreach to the Pediatric Cancer Advocacy Community.  November 18, 2014.  White Oak Campus, Silver Spring, MD. Topics will include background of pediatric drug development and approval process, role of the advocacy community, and topics/questions recommended by you (to be submitted when you register).  [Federal Register]

Science Board to the Food and Drug Administration Advisory Committee Meeting.  November 19-20, 2014. White Oak Campus, Silver Spring, MD. On November 19, the Science Board will review the existing nonclinical and clinical data related to the use and potential toxicity of anesthetics and sedation drugs in the pediatric population. The Science Board will be asked to make recommendations on steps the FDA should take to further evaluate and to mitigate the risks associated with the use of these drugs in the pediatric population and mechanisms to best communicate with the public regarding this issue. On November 20, among the agenda items will be consideration of a request to form a new subcommittee to evaluate the Centers of Excellence in Regulatory Science and Innovation program. [Federal Register]

Public Workshop. Brain-Computer Interface Devices for Patients With Paralysis and Amputation. November 21, 2014.  White Oak Campus, Silver Spring, MD.  The purpose of this workshop is to obtain public feedback on scientific, clinical, and regulatory considerations associated with BCI (Brain-Computer Interface) devices. Ideas and suggestions generated during this workshop may facilitate development of draft guidance to provide our initial thoughts regarding the content of premarket submissions for emerging BCI technologies to help speed development and approval of future submissions.  [Federal Register]    On September 30, 2014, FDA released a discussion paper in preparation for this workshop.  [FDA.gov]

Public Advisory Committee Meeting. Anesthetic and Analgesic Drug Products Advisory Committee. November 24-25, 2014. White Oak Campus, Silver Spring, MD. The committee will discuss the risk of serious neurologic adverse reactions associated with epidural steroid injections (ESI) administered to reduce inflammation for pain management. The committee will also consider the efficacy of ESI and the overall risk benefit balance of injecting steroids in the epidural space to treat pain. These considerations will assist the FDA in its discussions of possible regulatory options, including but not limited to changes to the product labeling. [Federal Register]

Public Advisory Committee Meeting. Blood Products Advisory Committee. December 2-3, 2014. White Oak Campus, Silver Spring, MD. On December 2, 2014, the Committee will meet in open session to hear scientific data related to reconsideration of the current blood donor deferral policy for men who have had sex with another man (MSM) even one time since 1977. An informational presentation will be made regarding the emergence of chikungunya virus infections in the Western Hemisphere and potential implications for blood transfusion safety. On December 3, 2014, the Blood Products Advisory Committee will be seated as a device classification panel. In open session, the panel will discuss the appropriate device classification of blood establishment computer software (BECS) and accessories to BECS. [Federal Register]

Meeting. Second Annual Meeting of C-Path and the Innovative Medicines Initiative. December 3, 2014. Bethesda, MD.  Entitled “Accelerating the development of drugs, diagnostics, and devices through partnerships that expand the precompetitive space,” the event aims to identify and address the challenges and opportunities of Public Private Partnerships (PPPs), e.g. mechanisms for assessing productivity and enhancing effectiveness, how to coordinate efforts and avoid duplication, and how to adopt best practices on data sharing. [More information]

Public Advisory Committee Meeting. Anti-Infective Drugs Advisory Committee. December 4, 2014. University of Maryland University College, Hyattsville, MD.  The committee will discuss issues related to clinical development programs and clinical trial designs for antibacterial products for the treatment of patients with serious bacterial infections for which there are limited or no therapeutic options. [Federal Register]

Meeting. Realizing the Benefits of the Unique Device Identifier in Health Care.  Office of the National Coordinator and Pew Charitable Trusts.  December 9, 2014. Washington, DC. This meeting will present discussion on the benefits and challenges of integrating the unique device identifiers (UDI) into clinical care, registries, the supply chain, and other facets of health care delivery. [FDA.gov]

New:  Expected January 2015.  Two-day public meeting on prioritization of Lab-Developted Tests (LDTs).  Information forthcoming.  (FDA.gov)

Public Policy Committee Meeting. Health Information Technology Policy Committee Advisory Meeting.  Monthly beginning January 13, 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 a policy framework for the development and adoption of a nationwide health information technology infrastructure that permits the electronic exchange and use of health information as is consistent with the Federal Health IT Strategic Plan and that includes recommendations on the areas in which standards, implementation specifications, and certification criteria are needed. [Federal Register]

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]


SECTION 4 OTHER REGULATORY AUTHORITIES & ORGANIZATIONS

Penn State to Auction Off Patents

Want to own the patent for expansin polynucleotides, related polypeptides, and methods of use developed at Penn State? Opening bid is $5,000.

Penn State plans to auction off 112 of its unused patents, spanning a range of disciplines from chemistry to engineering to bio-tech. All of the innovations at one time or another showed promise, but, for a variety of reasons, never found commercial success. Regardless of profit, the school is assessed maintenance fees by the U.S. Patent and Trademark Office ranging from $1,000 to $3,000, payable at defined intervals over the life of the patent.

The online auction will run from Dec. 8 to 12. A preview of the patents is available here. More also at link above. (NPR.org)

Ebola Contracts Worth $2 Billion Could Benefit Drugmakers

Drugmakers including Mapp Biopharmaceutical Inc., Johnson & Johnson and Emergent Biosolutions Inc. (EBS) are among companies standing to gain from what may be $2 billion in U.S. contracts related to Ebola. 

President Barack Obama asked Congress last week for $6.2 billion in emergency funding to stop the spread of the virus that has killed more than 4,800 people in West Africa. The request is heavily focused on health needs as opposed to prior funding that was largely centered on defense contracts, Brian Friel, a Bloomberg Intelligence contracts analyst, said.

Obama’s request includes goals to speed testing of vaccines and drugs overseas. Friel said he expects multiple drugmakers involved in Ebola will share in what will likely be no-bid contract awards to “make everyone happy.” His $2 billion estimate is based on the percentage of its budget the Department of Health and Human Services spent on contracts last year.  More at link above. (Bloomberg News)

Canada Passes New Drug Safety Law but Criticism Persists

Following sustained criticism that government oversight of prescription drug safety was lacking, Canada late last week passed Vanessa’s Law, which gives the Health Minister new authority over a wide range of practices involving both the pharmaceutical industry and the national regulatory agency.

Under the law, the Canadian health minister will now have the ability to recall drugs that are considered unsafe, clinical trial information will have to be posted in a public registry, drug makers will be compelled to upgrade product labeling and regulators must disclose decisions about their approvals – whether these are positive or negative.

Not everyone is sanguine, though. For instance, Russell Williams, who heads Rx&D, the pharmaceutical industry trade group in Canada, sent us a statement saying the organization supports the law, but has also “expressed concerned regarding the breadth of the provisions related to the release of confidential business information.” He did not elaborate.

At the same time, critics say the law addresses some gaps in oversight, but does not go far enough. Joel Lexchin, a professor at the York University School of Health Policy and Management in Toronto, says the law is “is necessary, but not sufficient. It still leaves a number of huge gaps in Canadian drug regulation.”  More at link above. (Pharmalot)

Judgement by European Union Civil Service Tribunal on appointment procedure of EMA Executive Director

The European Union Civil Service Tribunal has given its judgement on 13 November 2014 in a case involving an appeal by an individual against the selection procedure in 2011 for the appointment of the Executive Director of the European Medicines Agency (EMA).

The court has, on purely formal grounds, annulled the Commission’s decision adopting a shortlist of potential candidates for the position of Executive Director. As a consequence, the decision by the Management Board to select Guido Rasi from the shortlist and appoint him as Executive Director on 6 October 2011 has also been annulled.

Professor Sir Kent Woods, Chair of the Management Board, said, “I note with regret today’s judgement by the European Union Civil Service Tribunal. It is important to remember that the ruling is about a procedural formality. It is not a reflection on Guido Rasi’s competence or ability to run the Agency, something which he has done successfully since November 2011.”

The European Commission and EMA are taking legal advice. Pending further decisions, Andreas Pott, the Deputy Executive Director, will take responsibility with immediate effect for the management and operations of the Agency. (EMA.europa.eu)

European Medicines Agency welcomes new Head of Administration

The European Medicines Agency (EMA) is pleased to announce the appointment of Luc Vanheel as Head of the Administration Division as of 16 November 2014.

A Belgian national, Luc Vanheel previously worked at the European Aviation Safety Agency (EASA) where he served as Finance and Business Services Director.

With more than 30 years of experience in business administration in both the public and private sectors, Luc Vanheel has a strong background in resource management, support services, strategic and budgetary planning and reporting.

Throughout his extensive career Mr Vanheel has lived and worked in more than seven countries including Croatia, Belgium, Germany, Japan and Russia.  (EMA.europa.eu)

Regulatory information – New tool for companies to facilitate maintenance of information on authorised medicines

The European Medicines Agency (EMA) has made available a new tool to facilitate editing of key data fields by marketing-authorisation holders as part of the maintenance of information on authorised medicines that they have submitted to EMA.

This tool is available to users of the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Data-Entry Tool (EVWEB). A user manual explaining how to use this tool has been published.

As announced in January and June 2014, marketing-authorisation holders are required to complete previously submitted information on medicines with additional data elements that are included in the new data-submission format by the end of 2014. Companies are also required to bring medicine information up–to-date and to check that the quality of the information is in line with the updated reporting requirements. 

Companies are reminded that they need to complete this process by 31 December 2014. More at link above.  (EMA.eu)

Stakeholder feedback and experience continue to shape EMA’s understanding of commercially confidential information

The European Medicines Agency (EMA) has taken note of the European Ombudsman’s recent remarks on the Agency’s redaction of certain documents submitted by a pharmaceutical company. The Ombudsman is referring to an individual request for documents received and addressed by the Agency to the satisfaction of the requester in early 2014. A detailed reply to the European Ombudsman’s queries shall follow in due course.

Comments from the Ombudsman and other interested parties are a welcome addition to the ongoing debate on the concept of commercially confidential information. It is, however, important to stress that EMA is responsible for ruling on any redactions of documents to be published. The Agency always takes its decisions based on a careful assessment of the specific request and in accordance with existing laws and internal implementing rules.

EMA has been applying its concept of commercially confidential information in relation to clinical study reports since the publication of its access to documents policy in 2010 with the support of the medicines regulatory agencies of the European Union (EU) Member States.

While the EU legislation provides ample guidance on the protection of personal data, there is no agreed or binding definition of commercially confidential information. Based on experience and stakeholder feedback, the Agency is continuously improving its understanding of what can and cannot be considered confidential. More at link above.  (EMA.eu)

Herbal medicines 2004 – 2014: EMA celebrates ten years of harmonised standards across EU

Ten years since the introduction of the European legislation on herbal medicines, over 1,300 traditionally used herbal medicines have been registered, and more than 600 herbal medicines have been granted a marketing authorisation based on their well-established use in the EU Member States. These medicines are accompanied by clear and harmonised product information across the European Union, enabling citizens to make an informed choice when using herbal medicines for self-medication and healthcare professionals to base their prescription on comprehensive information on the medicines.

During the evaluation of herbal medicines, Member States rely on scientific opinions on herbal substances, known as European Union monographs, provided by the European Medicines Agency’s Committee on Herbal Medicinal Products (HMPC). These opinions contain information on the recommended therapeutic uses, any contraindications and interactions with other medicines and any potential undesirable effects. They are based on the review of all scientific data and information on the historic use of the herbal ingredients, including data on safety, efficacy and quality.

In addition to these scientific opinions, the HMPC has developed over 20 scientific guidelines that serve as common standards during the registration and authorisation of herbal medicines by Member States. They form a harmonised European backbone and a reliable reference for applicants when preparing national applications. More at link above. (EMA.eu)

China launches its biosimilars process

The China Food and Drug Administration has issued draft guidance that lays down principles for developing biosimilars of biologics already approved in China, including products intended to be extrapolated to multiple indications.

According to an unofficial translation commissioned by BioCentury, the agency's Center for Drug Evaluation describes in its "Guidelines for R&D and Evaluation Techniques of Biosimilars" a stepwise approach in which the number of confirmatory tests escalates based on the developer's ability to demonstrate equivalence in pharmacological, non-clinical and clinical development.

Under the "step-by-step" approach, the agency says "subsequent comparability tests may be exempted" once a biosimilar developer can demonstrate "no or little difference" compared to the reference product.

The draft stipulates that biosimilars should have the same amino acid sequence as reference products, which already must be registered in China. It also notes where special attention must be paid to complex biologics such as antibodies and antibody-drug conjugates (ADCs). More at link above. (BioCentury)

China Sets New Requirements for Hospitals Running Clinical Trials

The Chinese authorities are supplementing their current regulations around clinical trials with new mandates for the hospitals that conduct the studies.  Effective October 16, China’s National Health and Family Planning Commission recently released “Adminstrative Measure for the Clinical Study Projects of medical Institutions” with the CFDA and the Administration of Traditional Chinese Medicine. The measures are meant to supplement the current research regulations and should be read in conjunction with the general anti-corruption disciplinary rules in the “Nine Prohibitions” issued in late 2013. 

China currently regulates clinical trials via a compulsory ethics committee review, as well as through GCP governing drugs and devices, and a certification system to permit eligible hospitals to undertake studies.

A chief official of an Australian CRO with operations in China told Outsourcing Pharma that China is clearly attractive to run clinical trials in because of the size of the market and the impressive scale of hosptials, with ability to draw patients from 4,000 bed facilities.  “If pharma companies have the potential to market in China, they should consider running trials there to reduce the eventual time to market,” he said.  More at link above.  (Outsourcing Pharma)

DoP forms Task Force to promote growth of private sector in Pharma industry (India)
The Department of Pharmaceuticals (DoP) has constituted a Task Force on enabling the private sector to lead the growth of pharmaceutical sector in the country.  It is mandated to identify the challenges before the Indian pharmaceutical industry pertaining to various government departments and agencies.

The Task Force, headed by secretary, DoP, will focus on the need for integrated and coordinated thinking to promote the growth of the private sector in pharmaceutical sector.  It has been constituted by the DoP in compliance of the E-Samiksha monitoring system related action point.

The Task Force will identify the challenges before the Indian pharmaceutical industry pertaining to various government departments and agencies. It will also identify ways to ensure better coordination among various government departments and industry to facilitate the industry. More at link above. (PharmaBiz)

Japan: Increased Scrutiny of Pharma Support of Medical Research

Over the past year, clinical research conducted at several Japanese universities about a heart drug caused an unprecedented ruckus. At issue was trial data that was allegedly altered in order to make the heart medicine appear better than rival treatments.

As a result, articles in medical journals were retracted, and prosecutors filed charges against the company, which revamped management. A conflict of interest was acknowledged, because an employee had participated in the work but his employment was never publicly revealed.

The episode generated increased scrutiny in Japan over concerns that drug makers may unduly influence medical research. The pharmaceutical industry trade group, for instance, issued new policies that include rules about payments. The interest comes just as the U.S. federal government debuts a new web site that publishes payments that doctors receive from drug and device makers.

Now, a new analysis finds that the pharmaceutical industry paid more than $1.6 billion last year to doctors and hospitals in Japan for research, medical seminars and education, speaking fees and entertainment, according to the Japan News. Not surprisingly, nearly half, or 47%, went to research work. More at link above. (Pharmalot WSJ)


SECTION 5 LEGAL AND COMPLIANCE

Justice Department Probes Generic Companies After Price Hike Reports
A probe into the recent price hikes for some generic drugs appears to be widening. Last week, the U.S. Department of Justice issued subpoenas to two generic drug makers seeking information about their interactions with competitors.  The feds want documents about communication or correspondence with rivals about generic drug sales, but not any particular product or period of time, according to a filing with the U.S. Securities and Exchange Commission.

Digoxin has been cited as an example of a sudden spike in prices for some generic drugs, which are traditionally lower-cost alternatives to brand-name medicines and, therefore, are widely prescribed. About 86% of all prescriptions filled in the U.S. are for generic drugs, according to a report by the IMS Institute for Healthcare Informatics.

Impax and Lannett are two of the manufacturers that sell the medicine in the U.S. But last year, the price charged to pharmacies nearly doubled, according to a recent report in The New York Times that cited data from EvaluatePharma. This meant prices for consumers sometimes tripled, and began reaching as high as $50 for a one-month supply.

Digoxin once sold for just pennies a pill, according to the paper, which noted digoxin was not in short supply and there was no new patent or formulation to explain price increases. However, late last year, the paper pointed out several generic drug makers stopped making the pill and one company, it is not clear which, raised its price. More at link above. (Pharmalot WSJ)

Committee to Continue Oversight of Ebola Outbreak with Two Hearings Next Week
The Energy and Commerce Committee next week will continue its investigation of the ongoing Ebola outbreak and discuss the status of developing vaccines, diagnostics, and treatments for the virus. On Tuesday, November 18, the Subcommittee on Oversight and Investigations will continue its review of the United States’ response and preparedness efforts. On Wednesday, November 19, the Subcommittee on Health will hear from witnesses about the status of developing vaccines, diagnostics, and treatments for the virus.

The Subcommittee on Oversight and Investigations hearing, chaired by Rep. Tim Murphy (R-PA), will be held on Tuesday, November 18, 2014, at 1:00 p.m. in room 2123 of the Rayburn House Office Building. The hearing is entitled, “Update on the U.S. Public Health Response to the Ebola Outbreak.” Director of the Centers for Disease Control and Prevention Dr. Tom Frieden, Assistant Secretary for Preparedness and Response Dr. Nicole Lurie, and Acting Surgeon General Dr. Boris Lushniak will be among the witnesses testifying. The Majority Memorandum, a complete witness list, and witness testimony will be available here as they are posted.

The Subcommittee on Health hearing, chaired by Rep. Joe Pitts (R-PA), will be held on Wednesday, November 19, 2014, at 10:00 a.m. in room 2123 of the Rayburn House Office Building. The hearing is entitled, "Examining Medical Product Development in the Wake of the Ebola Epidemic." The Majority Memorandum, a witness list, and witness testimony will be available here as they are posted. (Energycommerce.house.gov)

Sens. Hatch, Alexander Expected To Lead Health Panels In Senate
Among the changes that Republican control of the Senate will bring will be new chairmen of the two committees with the most input into legislation pertaining to health care and pharmaceuticals: Finance and Health, Education, Labor & Pensions (HELP).

Sen. Orrin Hatch, R-Utah, is in line to take the helm of Finance, which has jurisdiction over federal health care programs including Medicare and Medicaid and other big-ticket items such as tax issues, trade policy and Social Security. Hatch – most famous among pharmaceutical industry stakeholders as one of the principal authors (along with retiring Rep. Henry Waxman, D-Calif.) of the drug patent reform law in 1984 that helped create the modern generic drug industry – brings a deep knowledge to the post and interest in industry concerns that could help ensure those concerns get a hearing on the committee's demanding agenda.

Lamar Alexander, R-Tenn., is expected to head HELP. But there can always be surprises when the new Congress convenes, for example if one senator makes an unexpected choice of committee or chairmanship and a domino effect of reshuffling ensues. Alexander, 74, won re-election on Nov. 4 and will start his third term as senator next year. He has not previously chaired a committee, but held a leadership post as chairman of the Senate Republican Conference and was formerly governor of Tennessee. Alexander has shown some familiarity and comfort with pharmaceutical issues – for example, he was involved in writing legislation giving FDA greater oversight over large-scale drug compounding facilities - and does not appear to be a significant wild card on the committee's future direction.

Hatch and Alexander have signed onto letters urging FDA to move along with regulations pertaining to biosimilars and generic drug labeling and provide better guidance to industry generally.  More at link above.  (Pink Sheet, paid subscription required)

Upton Regulatory Reform Project May Be Bigger, Bolder In Next Congress
Among the health legislative efforts that will likely gain momentum in the new Congress is Rep. Fred Upton’s 21st Century Cures project, the year-old effort to re-evaluate the regulatory process for medical product development and approval.

Upton, R-Mich., who chairs the House Energy and Commerce Committee, is aiming to release draft legislation by January, and the expanded Republican control of Congress could mean that the bill includes bigger, bolder proposals than it would have otherwise.

Some of legislative proposals that have been unveiled as likely candidates for the bill have so far have been unlikely to provoke dissent. But efforts to give greater regulatory weight to post-market registry data could have more of an impact on the drug development process, and there also appears to be serious consideration being given to expanding the marketing exclusivity period for new drugs, currently set at five years under the Hatch/Waxman legislation. More on this topic at link above. (Pink Sheet, paid subscription required)

Physician Payments Sunshine: Minnesota Releases Transparency Template
As the federal Sunshine Act has rolled out over the last year, Minnesota has been one of the few states that has added additional reporting requirements for drug (not device) manufacturers to track. By May 1, 2015, drug manufacturers must report on their 2014 transfers of value made to physician assistants, APRNs, dental therapists, and veterinarians. These entities are excluded from the Federal reporting obligations. This week, Minnesota has released its reporting payment template.

Minnesota Statute states that drug manufacturers must file an annual report identifying all payments, honoraria, reimbursement, or other compensation paid to practitioners in Minnesota during the preceding calendar year. The report must identify the nature and value of any payments totaling $100 or more to a particular practitioner during the year, and must identify the practitioner.  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.