Health Industry Washington Watch : Washington DC Healthcare Industry Law Firm : Reed Smith : Health Industry Washington Watch : Regulations, Medicare/Medicaid, Governmental Organizations

The GAO has issued a report, “New Drug Approval: FDA's Consideration of Evidence from Certain Clinical Trials,” examining FDA’s use of non-inferiority trial evidence as part of the drug approval process. According to the report, evidence from non-inferiority trials was included in 43 of the 175 new drug applications (NDAs) for new molecular entities submitted between FY 2002 and 2009, many of which were for antimicrobial drugs. As of December 31, 2009, FDA approved 18 of the 43 NDAs on the basis of evidence from non-inferiority trials (certain additional NDAs were approved based on other evidence). The GAO also examined the characteristics of these trials, and describes FDA’s guidance on these trials. According to GAO, “the agency has become more conservative in allowing evidence from non-inferiority trials to demonstrate a drug’s effectiveness,” both by limiting the indications for which these trials may be used and by becoming more rigorous in its review of evidence from non-inferiority trials. 

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The OIG has released a report entitled “Challenges to FDA’s Ability to Monitor and Inspect Foreign Clinical Trials.” The purpose of the report is to assess the volume of data submitted to FDA from clinical trials conducted in foreign countries, and to evaluate the extent to which FDA monitors and inspects foreign clinical trials. The report found that 80% of approved marketing applications for drugs and biologics contained data from foreign clinical trials, and the majority of clinical trial subjects and sites were located in foreign countries. The OIG reported that FDA inspected clinical investigators at less than 1% of foreign sites. The report noted that, in the absence of an investigational new drug application (IND), FDA has no mechanism for becoming aware of foreign trials; thus, it cannot effectively monitor them. The report recommends that FDA: (1) require standardized electronic clinical trial data; (2) create an internal database of clinical trial data; (3) monitor trends in foreign clinical trials not conducted under INDs; and (4) if necessary, take steps to encourage sponsors to file INDs.

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This post was written by Paul Sheives.

FDA issued a guidance document entitled “In Vitro Diagnostic (IVD) Device Studies -Frequently Asked Questions,” which is intended to help manufacturers and investigators regarding the development of IVD devices and IVD studies.  The guidance includes information on general regulatory issues, investigational studies, human subject protection, and data considerations. 

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This post was written by Paul Sheives.

FDA is hosting a public workshop and seeking input from industry, health care providers, and researchers on issues affecting the design and conduct of clinical studies for anti-bacterial drugs.  The primary focus of the workshop is the design and conduct of non-inferiority clinical studies, which are frequently used in the context of evaluating anti-bacterial drugs.  The meeting will be held on August 2-3, 2010, in Silver Spring, MD.   

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On May 20, 2010, HHS published a proposed rule to amend the Department’s regulations regarding the responsibility of applicants to promote objectivity in research for which Public Health Service (PHS) funding is sought. The proposed revisions are intended to expand and add transparency to investigator disclosure of significant financial interests and enhance regulatory compliance and effective institutional oversight and management of investigators’ financial conflicts of interests. HHS is proposing these changes in light of the increasingly complex interactions among the government, research institutions, and private sector entities involved with biomedical and behavioral research. HHS will accept comments on the proposed rule until July 20, 2010.

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This post was written by Areta Kupchyk.

The Institute of Medicine (IOM) has issued a report recommending that Congress grant FDA greater authority to require post-market surveillance of medical products approved primarily on the basis of surrogate endpoints. In the May 12 report entitled “Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease,” the IOM also recommends that FDA better harmonize its approach to evaluate biomarkers across the drug, device, biologic, and food centers, as well as convene expert panels to evaluate biomarkers and biomarker tests intended to have a regulatory impact.

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This post was written by Paul Sheives.

The FDA and the National Institutes of Health (NIH) have launched a website, called the Safety Reporting Portal (SRP), intended for the reporting of certain pre- and post-market safety data. In this early stage of development, industry can report adverse events occurring on human gene transfer trials, along with safety problems related to foods and animal drugs.

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This post was written by Paul Sheives.

FDA has released a new guidance from the International Conference on Harmonization (ICH) entitled “S9 Nonclinical Evaluation for Anticancer Pharmaceuticals.” The guidance is intended to assist in the design of an appropriate program of nonclinical studies for the development of anticancer pharmaceuticals. The guidance seeks to help sponsors identify the type and timing of nonclinical studies in relation to the development of anticancer pharmaceuticals, and addresses both non-clinical studies conducted to evaluate safety and clinical trial design and marketing.

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This post was written by Paul Sheives.

FDA has released a draft guidance document addressing the interpretability of non-inferiority (NI) clinical trials, as well as the proper approaches for determining the NI margin and analyzing results. The draft guidance contains four sections, which discuss: (1) the regulatory, study design, scientific, and statistical issues associated with NI studies for the purpose of showing efficacy; (2) the quantitative analytical and statistical approaches used to determine the NI margin for use in NI studies; (3) commonly asked questions about NI studies and provides practical advice about various approaches; and (4) five examples of successful and unsuccessful efforts to define NI margins and conduct NI studies. FDA is accepting comments on the draft guidance until June 1, 2010.

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This post was written by Paul Sheives.

FDA has issued a draft guidance document to help sponsors plan and conduct adaptive design clinical studies, and to aid agency staff in the efficient FDA review of such data. The guidance addresses topics such as: (1) aspects of adaptive design trials (e.g., clinical, statistical, regulatory) calling for special consideration; (2) tips for when to approach FDA while planning and conducting adaptive design studies; (3) suggested contents in the submission to FDA for review; and (4) considerations for the evaluation of a completed adaptive design study. FDA is accepting comments on the draft guidance until June 1, 2010. 

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This post was written by Paul Sheives.

The Food and Drug Administration (FDA) has published a proposed rule on “Reporting Information Regarding Falsification of Data,” which would require sponsors to self-report any “information indicating that any person has, or may have, engaged in the falsification of data” associated with study results (clinical or pre-clinical) relied upon by the sponsor. Under the new regulations, sponsors would be required to report any such information to FDA as soon as possible, but no later than 45 days after learning of the activity. FDA is accepting comments on the proposed rule until May 20, 2010. For more information, see http://edocket.access.gpo.gov/2010/pdf/2010-3123.pdf

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This post was written by Paul Sheives.

A draft guidance was issued by FDA to help institutional review boards (IRBs) fulfill their continuing review responsibility under FDA regulations by providing guidance on the criteria, process, and frequency ofcontinuing IRB review necessary to ensure that subjects in clinical trials are protected.  Although directed primarily at IRBs, the draft guidance should also assist sponsors and clinical investigators to fulfill their responsibilities related to continuing review. The FDA is seeking comments on the draft guidance by March 15, 2010 for consideration when drafting the final guidance.

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This post was written by Paul Sheives.

In an effort to better streamline medical device clinical trials, FDA issued a guidance document that addresses the use of Bayesian methods in medical device clinical trials. FDA provides a general overview of Bayesian methods and discusses how they intersect with the design and analysis of medical device clinical trials. The advantages and challenges inherent when using Bayesian methods are discussed, and FDA offers some comparisons to more standard statistical methods. In particular, FDA notes that this methodology allows companies to combine data collected in previous studies with data collected in a current trial, and the combined data may provide sufficient justification for smaller or shorter clinical studies. The use of Bayesian methods in post-market studies is explored as well.

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This post was written by Paul Sheives.

FDA recently issued a revision of an International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidance document, M3(R2), that was published in 1997 and is intended to harmonize and recommend international standards for non-clinical safety studies conducted to support human clinical trials of a given scope and duration, and/or to be relied upon for marketing authorization for pharmaceuticals. In this revised guidance document, FDA includes a new discussion relating to exploratory clinical studies. Also included are recommendations to help sponsors determine when certain nonclinical studies should be performed, such as phototoxicity studies, immunotoxicity studies, juvenile animal toxicity studies, and abuse potential studies.

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This post was written by Paul Sheives.

On December 29, 2009, the Food & Drug Administration Act (FDA) issued a proposed rule that would amend the informed consent regulations to require the addition of an element regarding disclosure of information to the National Institute of Health (NIH) clinical trials database. Under the Food and Drug Administration Amendments Act of 2007, sponsors of “applicable clinical trials” are required to submit information for listing in the NIH clinical trial database. The proposed rule would require all informed consents for such “applicable clinical trials” – including specified drug, biologic, and device clinical investigations -- to include language informing the subject of the potential disclosure of the de-identified data to the clinical trials database (www.clinicaltrials.gov). FDA is accepting comments on the proposal until March 1, 2010.

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The FDA has released final guidance for industry entitled "Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims." The document describes how FDA reviews and evaluates patient-reported outcome (PRO) instruments (i.e., a questionnaire plus supporting information and documentation) used to measure treatment benefit in medical product clinical trials. It also provides recommendations on how sponsors can use study results measured by PRO instruments to support claims in approved medical product labeling.

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This post was written by Paul Sheives.

On March 3-4, 2010, FDA is cohosting a public workshop in Orlando, Florida entitled "FDA Clinical Trial Requirements, Regulations, Compliance and GCP."
 

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The OIG has issued a report entitled “How Grantees Manage Financial Conflicts of Interest in Research Funded by the National Institutes of Health.” The OIG identified a number of vulnerabilities in National Institutes of Health (NIH) grantee institutions' identification, management, and oversight of financial conflicts of interest. For example, 90% of grantee institutions rely solely on researchers' discretion to determine which of their significant financial interests are related to their research and are therefore required to be reported. The OIG also found that nearly half of grantee institutions do not require researchers to disclose specific amounts of equity or compensation, and researcher-submitted financial interest information is not routinely verified. The OIG also found problems with documentation supporting grantee institutions’ oversight of financial conflicts of interest; failure of the majority of grantee institutions to have policies and procedures that address subgrantee compliance with financial conflicts of interest regulations; inconsistent reporting of conflicts; and the lack of a requirement that grantee institutions report to NIH any financial interests that they have with outside companies. According to the OIG, the most common type of financial conflict of interest among researchers is equity ownership in companies in which the financial interests could significantly affect the research. Other financial conflicts of interest among researchers involved inventing technology, consulting, or holding positions with outside companies. The OIG recommended a series of steps address such financial conflicts of interest, including strengthened grantee institution reporting and oversight requirements, the development of NIH guidance on methods to verify researchers' financial interests, and expanded NIH oversight and regulations addressing financial conflicts of interest.

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November 6, 2009, the Office for Human Research Protections (OHRP), Office of Public Health and Science published two notices announcing the availability of draft guidance on institutional review board (IRB) review of research. First, OHRP published a notice seeking comments on a draft policy entitled "Guidance on IRB Approval of Research with Conditions,” which would provide OHRP's first formal guidance on this issue. In particular, the document addresses such issues as: the circumstances that permit the IRB to approve research with conditions; how the IRB should handle changes to research that are proposed after initial IRB approval; how conditions on IRB approval affect ongoing research; and documentation of conditions of IRB approval of research. Comments will be accepted until January 5, 2010. The second draft document, "Guidance on IRB Continuing Review of Research," will supersede OHRP's January 15, 2007 document entitled "Guidance on Continuing Review." Among other things, the new draft guidance has been expanded to include a section on key IRB considerations when evaluating research undergoing continuing review and to provide more details regarding regulatory requirements and recommendations for the process for conducting continuing review. OHRP is accepting comments on the revisions until January 5, 2010.

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The Agency for Healthcare Research and Quality (AHRQ) has released a "Horizon Scan" entitled "To What Extent do Changes in Third-Party Payment Affect Clinical Trials and the Evidence Base?" The analysis examines the extent to which payment policies may be influencing clinical trial participant recruitment, participation, and retention rates   The report found that several large-scale clinical trials have encountered substantial difficulties due to the deterrent effect of payment policy on participation, with a bigger impact on medical device trials than drug trial. The report called for better coordination among all parties involved in trials, including a strategy covering which costs will be covered and which party will be responsible for such costs.

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This post was written by Paul Sheives.

FDA recently released two guidance documents (one in draft form) concerning hematopoietic reconstitution for specified indications as hematopoietic progenitor cells, cord (HPC-C), which provide information to manufacturers seeking licensure and potential sponsors for Investigational New Drugs Applications (INDs). FDA announced that it no longer intends to exercise enforcement discretion regarding IND and Biologics License Application (BLA) requirements for these products. The final guidance document is entitled “Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications,” and the draft guidance is entitled “Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications.” Other recent FDA guidance documents include the following:

• Labeling for Human Prescription Drug and Biological Products--Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information.
• Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.
• Guidance for Industry on Investigator Responsibilities: Protecting the Rights, Safety, and Welfare of Study Subjects.

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This post was written by Paul Sheives.

The GAO issued a report entitled "Oversight of Clinical Investigators: Action Needed to Improve Timeliness and Enhance Scope of FDA's Debarment and Disqualification Processes for Medical Product Investigators."   Among other things, the report raises concerns about the length of time associated with FDA disqualification proceedings. The GAO also found that FDA rules allow an investigator who is disqualified for conduct related to drugs or biologics to serve as an investigator for medical devices; likewise, an individual disqualified for conduct related to medical devices still may serve as a clinical investigator for drugs and biologics. In the report, the GAO recommends that the FDA Commissioner: pursue extending FDA’s debarment authority; extend disqualification to include drugs, biologics, and medical devices; and ensure the timely completion of debarment and disqualification proceedings.   FDA agreed with GAO’s recommendations.

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The FDA is seeking public input on the promotion of FDA-regulated medical products (including prescription drugs and biologics and medical devices) using the internet and social media tools (e.g., blogs, microblogs, podcasts, social networks and online communities, video sharing, widgets, and wikis). To that end, the FDA is hosting a public hearing in Washington, D.C. on November 12-13, 2009 to discuss this topic, and the agency is soliciting public comments through February 28, 2010. In particular, the FDA is requesting input on questions such as: (1) for what online communications are manufacturers, packers, or distributors accountable; (2) how can such entities fulfill regulatory requirements in their internet and social media promotion, particularly when using tools that are associated with space limitations and tools that allow for real-time communications; (3) what parameters should apply to the posting of corrective information on web sites controlled by third parties; (4) when is the use of links appropriate; and (5) how do adverse event reporting requirements apply to these formats.  

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The FDA is accepting comments on the following new draft guidance documents for industry:

• “Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation.” To be considered in drafting the final guidance, comments must be received by December 14, 2009. 
• “Microbiological Data for Systemic Antibacterial Drug Products Development, Analysis, and Presentation”; comments are due December 16, 2009. 
• “Clinical Considerations for Therapeutic Cancer Vaccines”; the comment deadline is December 17, 2009. 
• “Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses”; comments are due December 8, 2009. 

In addition, the FDA recently has issued a number of final guidance documents, including the following:

• “End-of-Phase 2A Meetings”;
• “Considerations for Allogeneic Pancreatic Islet Cell Products”;  and
• “Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers.”

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The FDA has released its annual report on the status of drug and biological product postmarketing studies and clinical trials, as required by the Food and Drug Administration Modernization Act of 1997.

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On October 29 – 30, 2009, the FDA is hosting a forum entitled “Pediatric Clinical Trials Workshop: Unmet Needs, Trial Designs and Clinically Meaningful Safety and Effectiveness Outcomes.” Comments regarding the public workshop will be accepted through November 30, 2009.  

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The Food and Drug Administration (FDA) has issued two final rules designed to further expand access to investigational drugs for treatment use and clarify when patients can be charged for investigational drugs.  The rules are effective October 13, 2009. The first rule, “Expanded Access to Investigational Drugs for Treatment Use,” clarifies existing regulations and makes access to investigational drugs for treatment use easier for individual patients, including in emergencies; intermediate-size patient populations; and larger populations under a treatment protocol or treatment investigational new drug application (IND).  The FDA intends for the rule to “improve access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions who lack other therapeutic options and who may benefit from such therapies.” The second final rule, “Charging for Investigational Drugs Under an Investigational New Drug Application,” clarifies the circumstances under which charging for an investigational drug in a clinical trial is appropriate; sets forth criteria for charging for an investigational drug for different population categories; and clarifies what costs can be recovered. The final rule will permit charging for a broader range of uses than was explicitly permitted previously. 

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On August 7, 2009, the FDA announced its enhanced procedures for debarment and clinical investigator disqualification with, among other things, increased staffing and centralized coordination, to ensure more rapid, transparent and consistent actions. The FDA notes that in the short time these measures have been in effect, the number of debarment actions has risen considerably while the times for resolving disqualification and debarment actions have been reduced significantly. The FDA also is posting disqualification and debarment proceeding information on its website to provide clinical study sponsors with ready access to information about FDA's actions. These policy changes are in response to concerns expressed by members of Congress that the FDA has not adequately used its debarment and disqualification authorities.

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The FDA is accepting comments on the following new draft guidance documents for industry:

• Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting; to be considered in drafting the final guidance, comments must be received by October 13, 2009.  
• Postmarketing Studies and Clinical Trials— Implementation of Section 505(o) of the Federal Food, Drug, and Cosmetic Act; comments are due October 13, 2009.

In addition, the FDA recently has issued a number of final guidance documents and “frequently asked question” documents, including the following:

• Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application.
• Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. 
• Frequently Asked Questions: Institutional Review Board Registration.
• Guidance for Industry on Abbreviated New Drug Applications: Impurities in Drug Substances (Revision 1).

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On June 25, 2009, the Agency for Healthcare Research and Quality's (AHRQ) Technology Assessment Program will be releasing a draft technology assessment on “Use of Bayesian Techniques in Randomized Clinical Trials: A CMS Case Study.” Comments on the draft will be accepted until July 10, 2009.

*** Update:  Comment period extended until July 17.

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On April 28, 2009, the Institute of Medicine (IOM) issued a report endorsing new voluntary and regulatory measures to strengthen protections against financial conflicts of interest in medicine. The report addresses conflicts of interest in a number of settings, including biomedical research, clinical care, physician training, and continuing medical education. Among other things, the IOM recommends improving disclosure of financial ties between the medical community and the pharmaceutical, biotechnology, and medical device industry; limiting company payments and gifts; stemming industry influence in medical education and the development of practice guidelines; and adopting safeguards pertaining to consulting arrangements.  

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On April 10, 2009, CMS issued a transmittal on billing routine cost of clinical trials, in which it announced that it is eliminating the need for differentiation between a diagnostic clinical trial service and a therapeutic clinical trial service. CMS also is providing that, for beneficiaries enrolled in a managed care plan, institutional providers must not bill outpatient clinical trial services and non-clinical trial services on the same claim. The policy is effective July 10, 2009.

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The House Energy and Commerce Subcommittee on Oversight and Investigations is holding a hearing March 26, 2009 on "Institutional Review Boards that Oversee Experimental Human Testing for Profit."

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The HHS Office of Inspector General (OIG) has issued a report on “The Food and Drug Administration's Oversight of Clinical Investigators' Financial Information,” which concludes that clinical investigators may not be disclosing all financial interests. The OIG found that only 1% of clinical investigators disclosed a financial interest, and the FDA cannot determine whether sponsors have submitted financial interest information for all clinical investigators. Further, FDA's oversight of such information is lacking, since: almost half of marketing applications were missing financial interest information; FDA reviewers did not document a review of financial interest information in almost one-third of marketing applications; and neither FDA nor sponsors took action to minimize potential bias in 22% of marketing applications with a disclosed financial interest. The OIG recommends that FDA ensure that sponsors submit complete financial information for all clinical investigators; use a review template and provide reviewer training; and require sponsors to submit financial information as part of the pretrial application process. While the FDA generally agreed with the recommendations, it did not agree to require sponsors to submit the financial information during the pretrial application process.

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On January 13, 2009, the FDA published a notice seeking comments on issues related to the enrollment of certain populations in clinical drug trials. This request is related to FDA's implementation of the Food and Drug Administration Amendments Act of 2007 (FDAAA) section 901, which requires the FDA to report to Congress on best practice approaches to increasing participation of elderly populations, children, racially and ethnically diverse communities, and medically-underserved populations in clinical drug trials. FDA requests comments from medical product manufacturers, IRBs, patient groups, researchers, and other interested parties on possible approaches to increasing participation of these groups in clinical drug trials. Comments will be accepted until February 27, 2009.

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The FDA has released final guidance on “Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007.” The guidance describes the FDA’s current thinking regarding the types of applications and submissions that sponsors, industry, researchers, and investigators submit to FDA and accompanying certifications under the FDAAA related to the submission of required information to the clinical trials data bank, www.ClinicalTrials.gov.

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HHS published a rule January 15, 2009 imposing registration requirements on institutional review boards (IRB) that review human subjects research conducted or supported by HHS and that are designated under an assurance of compliance approved for federal-wide use by the HHS Office for Human Research Protections (OHRP). The registration information will include contact information, numbers of all active protocols and active protocols involving research conducted or supported by HHS, and staffing for the IRB. The rule is effective July 14, 2009. Initial registration must be submitted by September 14, 2009, while IRBs currently registered with OHRP must comply by the three-year expiration date assigned by OHRP or within 90 days of certain IRB personnel changes. The FDA also issued a parallel rule to require IRBs to register through the HHS system and provide contact information and information on the number of active protocols involving FDA-regulated products and types of products reviewed. The rule is effective July 14, 2009, with a September 14, 2009 deadline for compliance with the initial registration requirement. In connection with the rule, the FDA released final guidance entitled “Adverse Event Reporting to IRBs -- Improving Human Subject Protection,” which is intended to help the research community interpret requirements for submitting reports of unanticipated problems, including certain adverse events reports, to IRBs. The document seeks to address concerns raised by the IRB community that increasingly large volumes of individual, unanalyzed adverse event reports are inhibiting the ability of IRBs to adequately protect human subjects.

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The Medicare Evidence Development & Coverage Advisory Committee (MedCAC) is meeting on Wednesday, March 18, 2009 to focus on the use of Bayesian statistics to interpret evidence in making coverage decisions. Bayesian analysis is a statistical technique in which prior evidence is used to update or to newly infer the probability that a hypothesis may be true. The meeting will introduce Bayesian concepts, contrast Bayesian approaches with frequentist approaches, and provide examples of using Bayesian techniques for meta-analyses. CMS encourages the participation of organizations with expertise in Bayesian statistics, meta-analyses, and clinical trial design and analyses. 

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The Food and Drug Administration Amendments Act of 2007 (FDAAA) expanded the public reporting requirements for “applicable clinical trials” involving certain drugs, biologicals, and devices. In December 2008, the Food and Drug Administration (FDA) issued a draft guidance document proposing, among other things, definitions that would affect who would be required to register certain clinical trials under the FDAAA. In some cases, FDA's proposal would require manufacturers who make grants to investigators to be the responsible party required to register. In addition, FDA elaborates on the circumstances under which clinical investigations designed to demonstrate bioequivalency would be subject to reporting. Additional background information is available at the clinicaltrials.gov web site. Reed Smith is reviewing the draft guidance. Please contact Areta Kupchyk at akupchyk@reedsmith.com for more information.

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On January 9, the Agency for Healthcare Research and Quality's (AHRQ) Technology Assessment Program posted for review a draft technology assessment entitled “Horizon Scan: To What Extent Do Changes in Third-Party Payment Affect Clinical Trials and the Evidence Base?”  Comments will be accepted until January 23, 2009.

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On December 1, 2008, the HHS Office for Human Research Protections (OHRP), Office of Public Health and Science, announced it is requesting public comments on a draft guidance document entitled “Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued.” The draft document is intended primarily for institutional review boards (IRBs), investigators, and funding agencies that may be responsible for the review or oversight of human subject research conducted or supported by HHS. OHRP will accept comments on the draft until January 30, 2009. In a related development, the FDA released guidance on “Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials,” which clarifies FDA's position that it is critical that data be retained from trial participants who decide to discontinue participation in a clinical study of an investigational product, who are withdrawn by their legally authorized representative, as applicable, or who were discontinued from participation by the clinical investigator. This Level 1 guidance is being issued for immediate implementation to prevent the potential loss of important clinical trial data.; if comments are received, the agency will review the comments and revise the guidance if appropriate. 

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The HHS Office for Human Research Protections has released its “Guidance on Engagement of Institutions in Human Subjects Research.” The guidance document describes whether certain scenarios would result in an institution being considered engaged in a human subjects research project, and addresses institutional review boards' review considerations for cooperative research in which multiple institutions are engaged in the same non-exempt human subjects research project. The guidance is intended primarily for IRBs, research administrators and other relevant institutional officials, investigators, and funding agencies that may be responsible for the conduct, review and oversight of human subject research that is conducted or supported by the U.S. Department of Health and Human Services. 

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CMS has issued an educational article clarifying issues related to Medicare payment of certain routine costs associated with clinical trials. The article focuses on the prohibition on payment for items or services which neither the beneficiary nor any other person or organization has a legal obligation to pay (i.e., items and services furnished gratuitously without regard to the beneficiary’s ability to pay and without expectation of payment from any source, such as free x-rays or immunizations provided by health organizations). CMS discusses the application of this policy in three scenarios: when a research sponsor says it will pay for routine costs if there is no reimbursement from any insurance company; when a research sponsor pays for the routine costs provided to an indigent non-Medicare patient; and when a research sponsor pays Medicare copayments for beneficiaries in a clinical trial. 

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There has been a flurry of recent legislative activity as the 110^th Congress prepares to adjourn in the coming days. Congress has taken action on a wide range of health policy bills, addressing such issues as FDA drug and device approvals, internet pharmacy regulation, health care workforce issues, insurance coverage, and medical treatment, and patent protection for antibiotics.   Specifically, the following legislation has been approved by the House and Senate and now await the President’s signature:

• H.R. 6353, the “Ryan Haight Online Pharmacy Consumer Protection Act,” which would prohibit the sale of controlled substances over the Internet without a valid prescription and subject on-line pharmacies to a series of new restrictions.
• S. 3560, the “QI Program Supplemental Funding Act,” which would authorize an additional $45 million for the Medicare Qualifying Individuals (QI) program, which helps certain low-income individuals pay their Medicare Part B premiums. The legislation also includes provisions to modify the patent protections applicable to antibiotics and clarify the ability of generic drug companies to gain approval of and market generic antibiotics. In addition, the bill would expand the education activities under the Medicaid Integrity Program (MIP) and extend funding for the Medicare Improvement Fund to make improvements under the original Medicare program. 
• Several measures aimed at expanding disease research and information resources, including: H.R. 1157, which would authorize grants for the development and operation of research centers for the study of environmental factors that may be related to the etiology of breast cancer; H.R. 1532, which would reauthorize the Preventive Health Services Regarding Tuberculosis program; H.R. 5265, which would promote research into the causes and treatments of various forms of Muscular Dystrophy; S. 1810, to authorize the HHS Secretary to collect and disseminate information regarding Down syndrome or other prenatally or postnatally diagnosed diseases and to coordinate the provision of support services for those who receive a diagnosis of one of those diseases; and S. 1382, which would authorize funding for the establishment of a national registry for the collection and storage of data on amyotrophic lateral sclerosis (ALS).

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The FDA has announced the availability of additional draft and revised draft product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). FDA will accept comments on the recommendations until December 4, 2008. Separately, the FDA has released draft guidance entitled “M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.'' The document, which discusses the types of nonclinical studies and their relation to the conduct of human clinical trials and marketing authorization for pharmaceuticals, is intended to facilitate the timely conduct of clinical trials and reduce the unnecessary use of animals and other drug development resources. The FDA is requesting comments on the draft guidance by October 20, 2008.

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