Author: Administrator

OIG Issues 2016 Final Rule Expanding Anti-Kickback Statute Safe Harbors; Excludes Pharmaceutical Manufacturers From Most Of Them

By Administrator

Our read of 81 Fed. Reg. 88368 (December 7, 2016), issued by U.S. Department of Health and Human Services’ Office of Inspector General (OIG), does not appear to affect pharmaceutical manufacturers in any substantive way; our obligations are unchanged and no additional “safe harbors” are afforded.

The OIG did make a technical correction to the safe harbor for referral services, which we believe requires an update to the “anti-kickback and fair market value” clauses in our clients’ templates. We’ll be using the italicized text below, from this point on:

Vendor represents and warrants that neither Vendor nor any individual or entity acting on Vendor’s behalf, nor any payee under this Agreement, will, directly or indirectly, offer, pay or accept, or authorize the offering, payment, or acceptance of, any money or anything of value to or from any third party, with the knowledge or intent that the payment, promise or gift, in whole or in part, will be made in order to improperly influence an act or decision that will assist Vendor, the Sponsor or the third party in securing an improper advantage or in improperly obtaining or retaining business or in improperly directing business to any person or entity.

Further, the parties acknowledge and agree that the amounts payable by Sponsor or Sponsor’s designee under this Agreement represent the fair market value of the covered costs associated with the Services and no part of any consideration paid hereunder is a prohibited payment for the recommending or arranging for the referral of business otherwise generated by either party for the other party or the ordering of items or services; nor are the payments intended to induce illegal referrals of business.

Phase III Clinical Trial Agreements: Ex-US Clinical Sites and FDA Inspections

By Administrator

With increasing frequency, an ex-US clinical site, in Poland or Hungary, for example, will delete all trial agreement references to compliance with FDA inspections (see sample text below), on the grounds that it is not required to comply with FDA inspections and/or is not subject to inspection by the FDA at all. In such cases, the site will seek to replace references to “FDA” with local, country-specific regulatory authorities.  However, foreign sites participating in clinical studies conducted under a FDA IND are subject to FDA inspections, and best practice dictates that the trial agreement should obtain the site’s agreement to notify sponsor’s in the event such an inspection takes place.

Sample ex-US trial agreement clause:

“The Institution and Investigator agree that personnel from regulatory authorities including but not limited to the United States Food and Drug Administration Food and Drug Administration (“FDA”) (“FDA”) may visit the Institution to inspect Study records (including portions of other pertinent records for all Research Subjects in the Study) and those procedures, facilities or Study records of any employee, contractor or agent that the Investigator or the Institution uses in conducting the Study. Investigator will notify Sponsor, promptly of any regulatory inquiries, investigations, site visits (whether announced or unannounced), correspondence or communication that relates to the Study and will consult and cooperate with Sponsor in responding to any such event, including providing documents, information and access as properly requested.Institution and Investigator will make all reasonable efforts to coordinate any scheduling of agency inspections to permit Sponsor and its designees to attend such inspections. Institution and Investigator will make reasonable efforts to segregate, and not disclose, any Records or other materials, correspondence and documents that are not required to be disclosed during such an inspection, including financial data and pricing information.  If the EC or any Regulatory Agency issues any notice, warning, demand, report or request related to the Study, Institution or Investigator, as applicable, shall send a copy of such document promptly to Sponsor, along with any proposed response to such document, before the same is submitted to the EC or any Regulatory Agency.”

By was of example, one can click here to view a 2015 Warning Letter, issued to a principle investigator, following a site inspection in France.

Of course, a sponsor may agree to a site request to omit reference to compliance with notification of an FDA inspection (remember, sponsors “audit” but the FDA “inspects”; the FDA does not “audit”, even though many in the industry use the terms interchangeably) in an effort to finalize the agreement in a timely manner. Our role at CA is to advise that the FDA can inspect any foreign site on a clinical study and we strongly urge sponsors to obtain a site’s agreement to be given immediate notice of any regulatory inspection during the study.

 

 

 

 

Journal of Commercial Biotechnology

By Administrator

Contracts Associates is proud to announce that Joanna Brougher has been named Editor-in-Chief of The Journal of Commercial Biotechnology .  We at CA will be submitting several articles over the next year or so, in an effort to continue to highlight changes and industry trends that will affect clinical trial contracting best practices.

Please feel free to submit ideas or queries directly to Joanna by emailing her directly at jbrougher@contractsassociates.com.

And I cannot end this post without wishing Joanna well at the USTA 2015 National Championship Adult 18 & Over Championships in Palm Springs on October 9th!

 

 

Random notes from ACI’s Women Leaders in Life Sciences Law Annual Meeting

By Administrator

I had the pleasure of attending the 2nd Annual ACI’s Women Leaders in Life Sciences Law meeting in Boston last week. While I originally registered to ensure that stay on top of the latest developments in the law that affect our Life Science community, I ended up getting a lot more out of the, for lack of a better word, “personal” disclosures, shared by the women leaders who spoke.

There were a lot of interesting exchanges and factoids, among them:

  1. PhRMA has only 30 member companies.
  2. Little-known effect of the ACA: Insurance companies have created “access tiers” for certain health plans so that, while the Affordable Care Act prevents them from denying one insurance for a pre-existing condition, only certain “tiers” will cover high-cost disease states. Consequently, the plan sold to a person who would have otherwise been denied, could cost more. I thought that the whole point of the “non-discrimination” clause was to to ensure :non-discrimination”?
  3. 22 US States have enacted their own, “Right to Try” (Abigail Alliance) laws. These laws allow patients to try unapproved drugs, after a successful Phase 1. There may be conflict with the FDA regs in some states but these conflicts are addressed on a case-by-case basis.
  4. Five countries have enacted or updated new Global Transparency Laws in the  past year. France, Denmark, Slovenia, Romania and Estonia have updated guidelines for paying any health care provider in those countries.
  5. “No. But being the only woman in the room makes people remember you, for a long time”  – Response to the following question, posed to a US District Court Judge, “Have there been any circumstances where being the only woman in the room, in a high-stakes meeting, actually contributed to a resolution or in some way helped further your cause?“

There was just not enough time to get into detail regarding those states that have passed “tissue property laws”, which restrict use of research tissue and bestow ownership of the tissues upon, in most cases, the patient, but those have to considered. We at CA will be doing a deep-dive into these new states laws and will provide an analysis here.

Thanks to the speakers who took the time to come to Boston for such a great conference; I am looking forward to next year’s meeting in Paris.