The pharmaceutical industry is taking its case for FDA development of rules or guidelines governing manufacturer/payer communications to the Center for Drug Evaluation and Research’s Medical Policy Council.

In comments on potential matters for the council’s consideration, the Pharmaceutical Research and Manufacturers of America said the CDER panel should “make it a priority for FDA to issue guidance to clarify the types of data and information that may be considered health care economic data” and appropriate dissemination of such information to payers, formulary committees and similar entities under Section 114 of the FDA Modernization Act of 1997.

CDER’s Medical Policy Council presents industry with a new venue to continue its longstanding push for clarity around the FDAMA provision governing communications with payers.

In a similar vein, the Medical Information Working Group, a coalition of 13 biopharma companies, urges the council to provide “much-needed clarity,” through comment and rulemaking, on policies governing manufacturer communications about unapproved uses of approved products, including communications to payers, and to consider more fundamental changes in FDA’s approach to regulating such communications.

While this is not the first time either PhRMA or MIWG has pushed FDA for more clarity on manufacturer/payer communications, their suggestion that these issues are ripe for consideration by the Medical Policy Council suggests a new pathway for focusing agency attention on the matter.

PhRMA Renews Call For Sec. 114 Guidance

CDER’s Medical Policy Council was established in 2012 with the aim of providing a senior-level forum for deliberations about medical policy issues and to ensure consistent application of medical policy throughout the drugs center Also see "Senior CDER Management Panel Could Facilitate Novel Therapy Approval" - Pink Sheet, 11 January, 2012.. The council also has been tasked with reviewing the more than 80 sponsor requests seeking breakthrough therapy designation for CDER-regulated products under the FDA Safety and Innovation Act.

In March, FDA announced the opening of a public docket for suggestions on potential topics for council consideration in any of nine general areas ([A#00130415012]).

PhRMA saw one of the nine areas, prescription drug promotion, as an opportunity to renew its pitch for formal agency guidance on FDAMA Sec. 114, which allows drug companies to disseminate health care economic information that is not in product labeling to formulary committees. Such information will not be considered false or misleading if it relates directly to an approved indication and is based on competent and reliable scientific evidence.

To date, FDA has provided little formal guidance on its interpretation of the competent and reliable standard. However, industry has viewed FDA officials’ statements and agency enforcement actions as indicative of a more restrictive “substantial evidence” standard ([A#00120227004]).

In September 2012, PhRMA submitted a white paper to FDA urging the development of formal regulatory guidance on Sec. 114. The paper asked the agency to allow for distribution to formulary committees of health care economic data based upon a range of data sources ([A#00121015019]).

Responding to stakeholder calls for clarity on the agency’s interpretation of Sec. 114, FDA Office of Prescription Drug Promotion Director Tom Abrams recently said dissemination of health care economic information was a topic being explored for future guidance development ([A#14130718005]). Nevertheless, PhRMA is now urging CDER’s Medical Policy Council to take up the issue.

In PhRMA's July 12 comments, the group said it is clear that Sec. 114 “contemplates the appropriate flow of economic information about treatments to payers, formulary committees and other similar entities to support informed judgments about drug coverage and reimbursement.”

However, without clear guidance from FDA on the scope of Sec. 114 or the circumstances under which health care economic information may be disseminated, biopharmaceutical companies have been reluctant to engage in such communications, PhRMA said. Given the potentially negative ramifications, such as the threat of government prosecution, associated with distributing this type of information about approved drugs, “some companies have made the decision not to invest in this research or to disseminate potentially informative data.”

In addition to calling on the council to ensure that guidance is developed, PhRMA said such a document “should make clear that information disseminated in a manner consistent with the agency’s recommendations would not be grounds for an enforcement or regulatory action from the agency.”

PhRMA also raises a separate issue related to the use of secondary endpoints in prescription drug promotion, saying there is a lack of clarity and guidance on presenting such data in marketing materials. “The MPC should consider recommending that FDA issue guidance on how to use scientific publications in promotional material,” PhRMA’s comments state. “While warning letters and untitled letters may be useful in clarifying FDA’s current thinking, they should not be used by the agency in place of formal guidance documents.”

MIWG Makes Its Pitch

The Medical Information Working Group makes a pitch for notice-and-comment rulemaking on interpretation of Sec. 114 and other issues pertaining to manufacturer communications about new uses of approved products.

In comments submitted July 16 by the law firms Ropes & Gray and Sidley Austin, MIWG urges the council to clarify issues raised in the industry group’s July 2011 citizen petition related to off-label communications.

In that petition, MIWG requested that FDA issue clarifying regulations on “scientific exchange” of information about investigational products, sharing information with formulary committees and payers, providing independent third-party clinical practice guidelines and responding to unsolicited requests for information Also see "FDA Pressed To Clarify Permissible Formulary, Clinical Guideline Communications" - Pink Sheet, 5 July, 2011..

Several months after MIWG’s petition was filed, FDA published a notice soliciting public comment on scientific exchange and announced the availability of a draft guidance on responding to unsolicited requests for off-label information Also see "Off-Label Use Discussions Should Stay Off-line, FDA Draft Guidance Says" - Pink Sheet, 2 January, 2012..

“To our knowledge no further action has been taken by FDA to address the petition’s requests for clarification of agency policies respecting distribution of clinical practice guidelines or communications with payers and related entities,” MIWG's comments state. “Moreover, we are aware of no effort to address the public comments that have been submitted to the agency on scientific exchange or unsolicited requests.”

MIWG requests the CDER council “consider the citizen petition in the context of the broad medical policy issues that we believe are presented by FDA’s current approach to manufacturer communications about new uses of approved products.”

“We ask the Medical Policy Council to consider the consequences of the current regulatory scheme for payers’ ability to make coverage and reimbursement decisions based on the full range of appropriate information and analysis,” MIWG said.

The group asserts that manufacturers currently cannot communicate adequately with payers and similar entities about their products, or provide information relevant to coverage and reimbursement decisions, because FDA has not addressed important questions surrounding Sec. 114 and the agency’s existing policies governing dissemination of information about off-label uses are inadequate.

“The payer dimension of the broader off-label communication problem illustrates the immediate need for concerted action by senior CDER leadership in this area,” MIWG said. “We ask the Medical Policy Council to consider the consequences of the current regulatory scheme for payers’ ability to make coverage and reimbursement decisions based on the full range of appropriate information and analysis.”

Other Agenda Items

Industry commenters’ recommendations of potential topics for council consideration extend beyond issues related to prescription drug promotion.

PhRMA and the Biotechnology Industry Organization call on the council to clarify clinical trial standards for certain disease subsets, such as use of intermediate clinical endpoints in slowly progressing diseases. BIO's July 16 comments also request the council take steps to improve the biomarker qualification process.

Both industry groups ask the council to consider establishing a policy regarding the level of evidence necessary to justify imposition of new safety study requirements, such as cardiovascular outcomes trials in chronic diseases, and for determining when and how to end such requirements. The council also could play a role in bringing more predictability and transparency to the proprietary name review process and improving the appeals process, the trade groups said.

PhRMA and BIO additionally call for more transparency into the council’s own functions, including how it will review and establish policies, whether its decisions will undergo a public review-and-comment process, and how final decisions will be communicated to stakeholders.

CDER Policy Council Urged To Address Manufacturer/Payer Communications

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