Life Science Compliance Update

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28 posts from September 2013

September 30, 2013

FDA: If the Government Shuts Down Tonight – Now What?

If the government shuts down tonight, Alexander Gaffney, News Editor at Regulatory Focus notes: "regulatory professionals are facing the prospect of something that hasn't happened since the last time a government shutdown occurred in 1995: a respite from new regulations or guidance documents from the US Food and Drug Administration (FDA)." About half of FDA will be furloughed; regulations and guidances will be put on pause. Alexander explores two key questions in his story:

Background and Effect on FDA

The current budget authority for the US government—including FDA—ends at midnight on 30 September 2013. Should legislators fail to either authorize a new budget or pass a continuing resolution (CR), all government personnel deemed to be "non-essential" would be furloughed. Some employees would be asked to stay at their posts, but would not be paid until a new budget is passed.

According to a statement posted on 27 September 2013 by the US Department of Health and Human Services (DHHS), FDA "would continue limited activities related to its user fee funded programs including the activities in the Center for Tobacco Products."

DHHS said out of a total of 14,779 FDA employees, 6,620 would be furloughed, leaving 8,180 (55%) retained.

FDA would have the staff in place to "continue select vital activities including maintaining critical consumer protection to handle emergencies, high-risk recalls, civil and criminal investigations, import entry review, and other critical public health issues," DHHS wrote. "Carryover funding from user fees paid by industry" might also support FDA in a shutdown, DHHS explained.

However, DHHS said "routine establishment inspections," some "compliance and enforcement activities," the "majority" of its laboratory research testing, and the "majority" of its food safety and nutrition testing would not be carried out.

In addition, it remains to be seen if FDA's advisory committees—essential for the review of new molecular entities and high-risk medical devices—would be convened according to schedule, or if they would be postponed. Advisory committee members are technically "special government employees," and might not be seen as "essential" under the law.

What about Regulations and Guidance?

But the DHHS document doesn't address one question of particular relevance for regulatory affairs professionals: What happens to regulations and guidance documents ordinarily released by FDA on a regular basis?

That question is answered in an advanced Federal Register notice due to be published on 30 September 2013 by the Federal Register Office (FRO).

In the notice, FRO explains that in the event of a government shutdown, it would only publish "documents directly related to the performance of governmental functions necessary to address imminent threats to the safety of human life or protection of property." FDA would be charged with making this determination for its own documents.

However, with most of its non-essential staff out of the office, it seems unlikely that FDA would be publishing many—if any—regulations of guidance documents, particularly since it would lack many of the staff who ordinarily support the release of those document (i.e. press officers). 

OFR also wrote that documents set to be published on shutdown days could be postponed "to permit a limited number of exempt OFR personnel to process emergency documents." 

One can also expect that no matter what the outcome delays on everything coming out of the government will ultimately be assigned to the shutdown as a catch all. Even though one could only expect the shutdown to last a few days, expect delays in months for things coming out of the FDA. Those social media guidance that everyone has been waiting on will take just a little while longer.

Physician Payment Sunshine Act: CME Coalition FAQ Supplement

 

In August of this year, we reported that the CME Coalition released a comprehensive guidebook to provide clear rules for participation in Sunshine-exempt Continuing Medical Education (CME) activities.

 

We have written about the guidebook previously, along with our numerous Sunshine-related posts.

 

The CME Coalition's Sunshine Act Compliance Guide will: "provide clarity on the CME Sunshine exemption to medical education providers, CME event sponsors, commercial supporters and physicians."

 

Consequently, the CME Coalition announced last week that it has updated the Frequently Asked Question (FAQ) section of the Guide. The updated FAQ supplement, includes important answers and citations to regulation intended to answer a number of questions, including:

 

  • how to handle attendee meals;
  • treatment of various accrediting bodies/rules; and
  • treatment of educational materials.

 

The FAQ supplement includes an index of categories and questions to provide assistance to stakeholders in finding quick access to questions and answers. Categories and questions include issues relating to:

 

  1. Accreditation (related to CME);
  2. Definitions of covered recipients and applicable manufacturers;
  3. Educational materials
  4. Stipends for post-activity outcomes reporting
  5. Meals & Travel
  6. Faculty, Speaker and Physician-Attendee Identity; and
  7. General questions

 

ACCME FAQ’s on Commercial Interests: Further Defines the ACCME Process for Faculty Financial Interests

The Accreditation Council for Continuing Medical Education (ACCME) recently produced a series of new Ask ACCME Q&A to regarding commercial support of CME activities. Below are the new FAQs.

As a reminder, the definition of "commercial interest" can be found within the ACCME Policies and Definitions.

What are examples of those in control of content as described in Standard for Commercial Support (SCS) 2.1?

SCS 2.1 requires that the accredited provider "must be able to show that everyone who is in a position to control the content of an education activity has disclosed all relevant financial relationships with any commercial interest to the provider."  If someone in connection to the activity has the opportunity to affect the content, they are "in control of content."  Those individuals in a position to control the content of an educational activity might include (but are not limited to) planners, faculty, authors, committee members, content reviewers, editors, and staff depending on the accredited provider's processes for developing educational activities. 

A common area of noncompliance with SCS 2 is that providers only collect information about relevant financial relationships from faculty or authors but do not collect that information from others, such as committee members, who may be in control of content.

Please note that SCS 6 requires that the relevant financial relationships of those in control of content be disclosed by the provider to learners prior to the educational activity. If providers do not gather information from all persons in control of content, as required by SCS 2, they will not be able to disclose the appropriate information to their learners for compliance with SCS 6.  For more information, see Standard 6.

In Standard for Commercial Support (SCS) 2, what does the ACCME consider a financial relationship, and what makes it relevant?

Financial relationships are those relationships in which the individual benefits by receiving, royalty, intellectual property rights, consulting fee, honoraria, ownership interest (e.g., stocks, stock options or other ownership interest, excluding diversified mutual funds), or other financial benefit. Financial benefits are usually associated with roles such as independent contractor (including contracted research), consulting, promotional speaking and teaching, membership on advisory committees or review panels, board membership, and other activities for which remuneration is received or expected. The ACCME considers relationships of the person involved in the CME activity to also include financial relationships of a spouse or partner.

Relevant financial relationships are financial relationships in any amount, which occurred in the twelve-month period preceding the time that the individual was asked to assume a role controlling content of the CME activity, and which relate to the content of the educational activity, causing a conflict of interest. The ACCME considers financial relationships to create conflicts of interest in CME when individuals have both a financial relationship with a commercial interest and the opportunity to affect the content of CME about the products or services of that commercial interest. The potential for maintaining or increasing the value of the financial relationship with the commercial interest creates an incentive to influence the content of the CME—an incentive to insert commercial bias. 

The ACCME has not set a minimum dollar amount for relationships to be considered relevant and does not use the term significant to describe financial relationships. Inherent in any amount is the incentive to maintain or increase the value of the relationship.

Does the ACCME require a signed disclosure form as the means to demonstrate compliance with Standard for Commercial Support (SCS) 2.1?

No. The ACCME does not require that providers use a disclosure form to gather information about relevant financial relationships of all persons in control of the content of an educational activity.  A disclosure form is one mechanism that providers may use to obtain (and show that they possess) this information.  Other examples could include:

  • Collecting the information verbally and recording it in a spreadsheet, table, or database
  • Collecting disclosure information electronically (for example, via e-mail, web-based form, or database)

The ACCME requires accredited providers to obtain information about the relevant financial relationships of all persons in control of content. The obtaining of this information must be a key component of several processes in order to ensure the independence of educational activities (see Criterion 7). Providers may choose the mechanism(s) to obtain this information that best suit their organizational needs and can be used to demonstrate compliance to the ACCME.

What is the difference between significant financial relationships and relevant financial relationships?

First, it is important to understand how the ACCME defines a financial relationship. Financial relationships are those relationships in which the individual benefits by receiving, royalty, intellectual property rights, consulting fee, honoraria, ownership interest (e.g., stocks, stock options or other ownership interest, excluding diversified mutual funds), or other financial benefit. Financial benefits are usually associated with roles such as independent contractor (including contracted research), consulting, promotional speaking and teaching, membership on advisory committees or review panels, board membership, and other activities for which remuneration is received or expected. ACCME considers relationships of the person involved in the CME activity to also include financial relationships of a spouse or partner.

Relevant financial relationships are financial relationships in any amount, which occurred in the twelve-month period preceding the time that the individual was asked to assume a role controlling content of the CME activity, and which relate to the content of the educational activity, causing a conflict of interest. The ACCME considers financial relationships to create conflicts of interest in CME when individuals have both a financial relationship with a commercial interest and the opportunity to affect the content of CME about the products or services of that commercial interest. The potential for maintaining or increasing the value of the financial relationship with the commercial interest creates an incentive to influence the content of the CME—an incentive to insert commercial bias.  The ACCME has not set a minimum dollar amount for relationships to be considered relevant and does not use the term significant to describe financial relationships. Inherent in any amount is the incentive to maintain or increase the value of the relationship.

To be compliant with Criterion 7 (Standards for Commercial Support 2 and 6), accredited providers should be obtaining disclosure of relevant financial relationships from all persons in control of content.  If providers are asking those individuals in control of content to disclose significant financial relationships or setting a minimum dollar amount for disclosures, they will not be compliant with SCS 2 and SCS 6.

Do I need to obtain disclosure of relevant financial relationships directly from the spouse or partner of a person who is in a position to control the content of a CME activity? (Standard for Commercial Support 2.1)

No. ACCME considers relationships of the person involved in the CME activity to include financial relationships of a spouse or partner.  The ACCME expects that providers will communicate to everyone who is in a position to control of content of an educational activity that the individual's disclosure of relevant financial relationships must include:

  • financial relationships in any amount,
  • including financial relationships of their spouse or partner,
  • within the 12 months prior to the educational activity,
  • with an ACCME-defined commercial interest, and
  • that relate to the content of the educational activity

What is the difference between disclosure in Standard for Commercial Support (SCS) 2 and disclosure in SCS 6?

Disclosure is an expectation in Criterion 7 for both Standard 2 and Standard 6 of the ACCME Standards for Commercial Support: Standards to Ensure Independence in CME Activities (SCS).

SCS 2.1 requires that anyone who is in a position to control the content of an education activity disclose information to the accredited CME provider about relevant financial relationships that the individual and their spouse or partner have with ACCME-defined commercial interests. This information is used by the provider to meet the expectations of SCS 2.3 and SCS 6.

In SCS 6, disclosure is made by the accredited CME provider to learners prior to the beginning of an educational activity. This disclosure is part of CME's accountability to the public – by providing participants of a CME activity with information that may inform their perspectives on the content of the educational activity.  In order to be compliant with this expectation, providers need to communicate to the participants both those relevant financial relationships that they discovered in their process of complying with SCS 2.1 as well as the source of all financial support – both monetary and in-kind – given to the provider from commercial interests for the activity.  In addition, this information must be conveyed prior to the start of the activity.

What information do I need to collect in order to be compliant with Criterion 7, Standard for Commercial Support 2 (SCS 2)?

SCS 2.1 says that providers "must be able to show that everyone who is in a position to control the content of an education activity has disclosed all relevant financial relationships with any commercial interest to the provider." Therefore, the provider must do both of the following:

  • Collect information from everyone in control of content, meaning anyone that has the opportunity to affect the content, including, but not limited to planners, faculty, authors, committee members, content reviewers, editors, and staff depending on the accredited provider's processes for developing educational activities
     
  • Collect information about relevant relationships with any commercial interest, meaning
    • ​financial relationships in any amount,
    • including financial relationships of their spouse or partner,
    • within the 12 months prior to the educational activity,
    • with an ACCME-defined commercial interest, and
    • That relate to the content of the educational activity

SCS 2.2 and 2.3 then go on to tell the provider what actions need to happen as a result of collecting that information:

SCS 2.2 – If anyone refused to provide the information described above to the provider, then that person must be disqualified from having any control over the educational content of the activity.

SCS 2.3 – The provider must implement a mechanism to determine if the relevant financial relationships that were disclosed create a conflict of interest and then resolve those conflicts of interest.

Providers will not be in compliance with SCS 2 if they do any or all of the following:

  • Only collect information about significant financial relationship or set a minimum dollar amount for disclosure
  • Do not advise individuals that they should also report the relevant financial relationships of their partners or spouses
  • Do not gather information about relationships within the 12 months prior to the educational activity
  • Use a definition of commercial interest that is incomplete, outdated, or different than the complete, current ACCME definition (see below)

In addition, providers will not be able to demonstrate compliance with SCS 6, disclosing relevant financial relationships to the learner, if they have not gathered the correct information in SCS 2.

Please note that the ACCME expanded the definition of commercial interest in 2007. The current definition reads: "A commercial interest is any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients." CME providers must use the complete definition in their processes and tools. Failure to use the complete definition could cause an accredited provider to:

  • partner with an ACCME-defined commercial interest;
  • collect incomplete information related to the relevant financial relationships of those in control of content; and therefore
  • not resolve all conflicts of interest; and/or
  • not disclose all relevant financial relationships to learners.

This could lead to one or more noncompliance findings in Criterion 7 (Standards for Commercial Support 1, 2, and 6).

 

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