Life Science Compliance Update

February 10, 2017

FDA Finalizes Guidance on Assigning Non-Proprietary Names to Biologics and Biosimilars

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Recently, the Food and Drug Administration (FDA) finalized guidance detailing its approach to assigning non-proprietary names to biologics and biosimilars. The guidance, titled “Nonproprietary Naming of Biological Products,” finalizes an August 2015 draft of the same title. In the final guidance, the FDA says a biologic product’s nonproprietary name (“proper” name) will consist of two components: a “core name” and a distinguishing suffix (with no specific meaning) composed of four letters. The FDA, however, did not finalize an approach to the suffix format for interchangeable products.

Scope

The FDA intends to apply the naming convention to both newly licensed and previously licensed biological products. The FDA is also continuing to consider the process for implementation of the naming convention for previously licensed products but, for right now, intends to assign distinguishing suffixes to a limited group of these products and will accept submissions of prior approval labeling supplements that include proposed suffixes.

Core Name

FDA says the core name will be the name designated by the USAN Council for the originator biologic product, and that any related biological product, biosimilar product, or interchangeable product will have the same core name. The FDA notes in the guidance that “use of a shared core name will indicate a relationship among products.”

Distinguishing Suffix

For the second component of a product’s proper name, the FDA says “a distinguishing suffix that is devoid of meaning and composed of four lowercase letters will be attached with a hyphen to the core name of each originator biological product, related biological product, or biosimilar product.” The agency notes that its choice of using a suffix rather than a prefix will help products with the same core name being grouped “together in electronic databases to help health care providers locate and identify these products.”

Inadvertent Substitution

The finalized naming approach “should help prevent inadvertent substitution” which can lead to “unintended alternating or switching of biological products that are not determined by FDA to be interchangeable with each other,” the agency says. The FDA notes the distinguishing suffix should clear up potential confusion when related biological products are licensed for different indications, different routes of administration, or fewer than all indications for which the reference product is licensed.

The FDA also says the unique suffix should also prevent confusion among health care providers who, “based on their experience with small-molecule drugs and generic versions of those drugs, may incorrectly assume that FDA has determined biological products with the same proper name to be interchangeable.”

Interchangeability

In the guidance, the FDA says that it is continuing to consider the appropriate suffix format for interchangeable products. The FDA says it intends to apply a naming convention to interchangeable products that will feature a core name and a suffix included in the proper name; however, FDA is continuing to consider the appropriate format of the suffix for these products.

In addition, FDA requests that biologic and biosimilar applicants and application holders propose a suffix composed of four lowercase letters for use as the suffix included in the proper name.

January 26, 2017

FDA Releases Draft Guidance on Manufacturer Communications with Payors, Formulary Committees, and Similar Entities

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In mid-January 2017, the United States Food and Drug Administration (FDA) released a guidance document, entitled Drug and Device Manufacturer Communications with Payors, Formulary Committees and Similar Entities – Questions and Answers,” explaining FDA’s current thinking regarding communications by medical product manufacturers, packers and distributors of health care economic information (HCEI) about approved prescription drugs to payors and formulary committees.  The draft guidance also provides answers to common questions about dissemination of information by firms regarding investigational drugs and devices to payors before FDA clearance or approval of those products.

HCEI is defined in the document as “any analysis (including the clinical data, inputs, clinical or other assumptions, methods, results, and other components underlying or compromising the analysis) that identifies, measures, or describes the economic consequences of the represented health outcomes, of the use of a drug.” HCEI pertains to the economic consequences related to the clinical outcomes of treating a disease (or specific aspect of a disease) or of preventing or diagnosing a disease. According to the FDA, HCEI may be presented in a variety of ways that can include, but are not limited to, an evidence dossier, a reprint of a publication from a peer-reviewed journal, a software package comprising a model with user manual, or a budget-impact model.

HCEI is not to be considered false or misleading if, among other things, it “relates to an [approved] indication.” To be considered related to an approved indication, HCEI analyses should relate to the disease or condition, manifestation of the disease or condition, or symptoms associated with the disease or condition in the patient population for which the drug is indicated in the FDA-approved labeling. Pages six through eight of the guidance have a table of HCEI analyses that relate to the approved indication.

In the guidance document, FDA defines “payors” as including payors, formulary committees, or other similar entities responsible for making drug selection, formulary management and/or coverage and reimbursement decisions regarding drugs and/or devices for health care organizations, including integrated health care delivery networks, hospitals and hospital systems.  In the guidance, FDA notes that if a firm disseminates HCEI about an approved drug consistent with the guidance, when finalized, FDA does not intent to consider such information false or misleading or as providing evidence of a new intended use.

In an accompanying Federal Register notice, FDA announced that it is reopening the comment period related to a previous public hearing concerning manufacturer communications regarding unapproved uses of approved or cleared medical products. This comment period will be reopened for 90 days, beginning January 19, 2017.

January 25, 2017

Final Common Rule - Sixteen Agencies Update Regulations on Individuals Who Participate in Human Research

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The Department of Health and Human Services (HHS), along with fifteen other federal agencies, issued a final rule updating regulations that safeguard individuals who participate in research. The rule updates current regulations, known as the “Common Rule,” which has been in place since 1991, and finalizes a September 2015 proposal. The rule does not become effective until January 19, 2018, although cooperative research is not required to be compliant until January 20, 2020.

Since the Common Rule was promulgated, the volume and landscape of research involving human subjects have changed considerably. Research with human subjects has grown in scale and become more diverse. Examples of developments include: an expansion in the number and types of clinical trials, as well as observational studies and cohort studies; a diversification of the types of social and behavioral research being used in human subjects research; increased use of sophisticated analytic techniques to study human biospecimens; and the growing use of electronic health data and other digital records to enable very large datasets to be rapidly analyzed and combined in novel ways. However, these developments have not been accompanied by major change in the human subjects research oversight system.

HHS notes that the rule seeks to strengthen “protections for people who volunteer to participate in research” while balancing administrative burden, particularly for low-risk research.

According to HHS, more than 2,100 comments were received and as such, the final rule contains a number of significant changes from the proposed rule. Proposed policies that were ultimately not adopted include:

  • The final rule does not adopt the proposal to require that research involving non-identified biospecimens be subject to the Common Rule, and it does not require that consent be obtained to conduct such research. In general, researchers can continue to use such biospecimens in the way they are currently using them.
  • To the extent that some of the NPRM proposals relied on tools or standards that had not yet been proposed, the final rule either does not adopt those proposals or includes revisions to eliminate such reliance. Examples of items that were not included in the final rule include a template to be used for broad consent forms, and a decision tool to be used for making exemption determinations.
  • The final rule does not expand the policy to cover clinical trials that are not federally funded.
  • The final rule does not adopt the NPRM’s proposed concept of “excluded” activities. Generally, activities proposed to be excluded are now described as not satisfying the definition of what constitutes research under the regulations or are classified as exempt.
  • The final rule does not include the proposed standardized privacy safeguards for identifiable private information and identifiable biospecimens. Instead, in most respects, it retains the current approach to privacy standards.
  • The final rule does not adopt the proposal for more stringent criteria for obtaining a waiver of the consent requirements for identifiable biospecimens.

Some of the significant changes made to the Common Rule include:

  • Establishes new requirements regarding the information that must be given to prospective research subjects as part of the informed consent process.
  • Allows the use of broad consent (i.e., seeking prospective consent to unspecified future research) from a subject for storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens. Broad consent will be an optional alternative that an investigator may choose instead of, for example, conducting the research on nonidentified information and nonidentified biospecimens, having an institutional review board (IRB) waive the requirement for informed consent, or obtaining consent for a specific study.
  • Establishes new exempt categories of research based on their risk profile. Under some of the new categories, exempt research would be required to undergo limited IRB review to ensure that there are adequate privacy safeguards for identifiable private information and identifiable biospecimens.
  • Creates a requirement for U.S.-based institutions engaged in cooperative research to use a single IRB for that portion of the research that takes place within the United States, with certain exceptions. This requirement becomes effective 3 years after publication of the final rule.
  • Removes the requirement to conduct continuing review of ongoing research for studies that undergo expedited review and for studies that have completed study interventions and are merely analyzing study data or involve only observational follow up in conjunction with standard clinical care.

An HHS press release on the rule is available here.

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