Thursday, July 16, 2009

Terms of the Merck-Schering-Plough State Pricing Investigation Settlement


UPDATED: Marilyn Mann's well-turned piece on this is up, over at Gooznews. Do go see it.

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Courtesy of Marilyn Mann, here is the whole PDF file (14 pages) -- and the business portions of it (very similar to Vioxx settlement terms). Note particularly, that for at least the next seven years, Merck (and Schering-Plough) must submit all covered drug/device product "direct-to-consumer" TV advertising to FDA for pre-approval (Paragraph 8) -- not just the Vytorin/Zetia ads (as originally reported in the mainstream media):
. . . .Paragraph 8:

Merck agrees to submit all new DTC television advertising campaigns for any Merck Product to FDA for pre-review, wait until Merck receives a response from FDA prior to running the advertising campaign, and to modify such advertising consistent with any written comments received from FDA.

Paragraph 9:

Merck’s obligations with respect to Paragraph 7 shall remain in effect for ten years following the Effective Date. Merck’s obligations with respect to Paragraph 8 shall remain in effect for seven years following the Effective Date. With respect to Paragraph 7, Merck shall abide by any such written recommendation as long as the submission of the TV advertising campaign is made within ten years following the Effective Date. With respect to Paragraph 8, Merck shall abide by any such written recommendation when such submission is made within seven years of the Effective Date.



Paragraph 10:

When presenting information about a Clinical Study that relates to an FDA-approved Merck Product in detailing pieces, brochures, booklets, mailing pieces, published journals, magazines, other periodicals and newspapers, and broadcast through media such as radio, television, the Internet, and telephone communications systems Merck shall (1) accurately reflect the methodology used to conduct the Clinical Study; (2) shall not present favorable information or conclusions from a study that is inadequate in design, scope, or conduct to furnish significant support for such information or conclusions; and (3) shall not use statistical analyses and techniques on a retrospective basis to discover and cite findings not soundly supported by the study, or to suggest scientific validity and rigor for data from studies the design or protocol of which are not amenable to formal statistical evaluations.

Paragraph 11:

When presenting information about a Clinical Study or analysis of Clinical Studies as evidence of an FDA-approved Merck Product’s safety in detailing pieces, brochures, booklets, mailing pieces, published journals, magazines, other periodicals and newspapers, and broadcast through media such as radio, television, the Internet, and telephone communications systems, Merck shall not (1) present information from a study in a way that implies that the study represents larger or more general experience with the drug than it actually does; nor (2) use statistics on numbers of patients, or counts of favorable results or side effects, derived from pooling data from various insignificant or dissimilar studies in a way that suggests either that such statistics are valid if they are not or that they are derived from large or significant studies supporting favorable conclusions when such is not the case.

Paragraph 12:

When presenting information about a Clinical Study or analysis of Clinical Studies as evidence of an FDA-approved Merck Product’s safety in detailing pieces, brochures, booklets, mailing pieces, published journals, magazines, other periodicals and newspapers, and broadcast through media such as radio, television, the Internet, and telephone communications systems, Merck shall not (1) present favorable information or conclusions from a study that is inadequate in design, scope, or conduct to furnish significant support for such information or conclusions; (2) use the concept of statistical significance to support a claim that has not been demonstrated to have clinical significance or validity, or fails to reveal the range of variations around the quoted average results; nor (3) use statistical analyses and techniques on a retrospective basis to discover and cite findings not soundly supported by the study, or to suggest scientific validity and rigor for data from studies the design or protocol of which are not amenable to formal statistical evaluation.

Paragraph 13:

(a) Merck shall comply with the ACCME Standards for Commercial Support, a copy of which is attached hereto as Appendix 1.

(b) Any person who acts in a promotional capacity for Merck with respect to an FDA approved Merck Product shall be obligated under his or her contract with Merck, as a condition for any future promotional relationship with Merck, to disclose to CME participants orally and to the CME provider for inclusion in the written materials the existence, nature and purpose of his or her arrangement with Merck when speaking at a CME program if: (i) the Product the speaker promoted for Merck is in the same therapeutic category as the subject of the CME program, and (ii) the CME program occurs within 12 months of the speaker performing work for or receiving compensation from Merck. Such disclosure shall set forth the type of promotional work engaged in by the speaker and the name of the therapeutic category with respect to which such promotion was performed.

(c) Merck shall not provide funding for CME when Merck has knowledge at the time the decision to fund the CME is made that a speaker at the CME has also been a promotional speaker in the past 12 months at a Merck-sponsored promotional event related to the class of drugs to be discussed in the CME.

Paragraph 14:

Merck’s obligations with respect to CME shall remain in effect for 9 years following the Effective Date. Merck’s obligations with respect to Paragraph 13(b) shall only apply to speakers’ contracts entered into, amended to extend the contract period, or renewed after the date of this Agreement.

Paragraph 15:

All members of any external Data Safety Monitoring Board (“DSMB”) constituted by Merck after the Effective Date for a Merck-Sponsored Clinical Trial shall be prohibited from:

(a) holding more than $25,000 of Merck stock (exclusive of mutual fund holdings) at the time of DSMB membership;

(b) trading in Merck stock during their DSMB service;

(c) serving as a clinical trial investigator in the trial being monitored by the DSMB;

and

(d) consulting for, being employed by, or entering into any future consulting or employment relationships with Merck while serving on the DSMB, except that DSMB members may (i) concurrently serve on other DSMBs for Merck, and/or (ii) consult for Merck Research Laboratories where the annual aggregate compensation for such non-promotional consulting services does not exceed $15,000.

Paragraph 16:

Merck’s obligations with respect to DSMB membership set forth in Paragraph 15 shall remain in effect for DSMBs constituted within 7 years following the Effective Date.

Paragraph 17:

Merck agrees to enhance further its process for reviewing potential conflicts of interest such that all members of a DSMB shall, prior to service thereon, complete a “competing interests” form which shall include questions regarding consulting arrangements or frequent speaking arrangements with the sponsor; career involvement with a product or technique under study; hands-on participation in the trial; emotional involvement in the trial; intellectual conflicts; involvement in regulatory issues relevant to trial procedures; investment in competing products; and involvement in the publication. The forms shall carry a continued updating obligation and shall be forwarded to, and reviewed by, the DSMB chair who, in turn, will forward them to the study’s Steering Committee chair or other appropriate individual for review and action, as needed, in advance of the first DSMB meeting and on an ongoing basis.

Paragraph 18:

Merck shall require all individuals who are named as authors on a Merck-sponsored manuscript reporting the results of a Merck-sponsored study to fulfill the following conditions: (a) the individual shall have made substantial contribution to the conception and design, or acquisition of data, or analysis and interpretation of data; (b) the individual shall have been involved in drafting the article or revising it critically for important intellectual content; and (c) the individual shall have final approval rights of the version to be published.

Paragraph 19:

When a large, multi-center group has conducted the research, the manuscript should identify the individuals who accept direct responsibility for the manuscript. These individuals should fully meet the criteria for authorship defined in Paragraph 18 above.

Paragraph 20:

By its execution of this Judgment, State of Florida releases Merck and all of its past and present subsidiaries, affiliates, predecessors and successors (collectively, the “Released Parties”) from the following: all civil claims, causes of action, damages, restitution, fines, costs, and penalties on behalf of the State of Florida under the above-cited consumer protection statutes arising from the Covered Conduct that is the subject of this Judgment.

Paragraph 21:

Notwithstanding any term of this Judgment, specifically reserved and excluded from the Release in Paragraph 20 as to any entity or person, including Released Parties, are any and all of the following:

a. Any criminal liability that any person or entity, including Released Parties, has or may have to the State of Florida.

b. Any civil or administrative liability that any person or entity, including Released Parties, has or may have to the State of Florida under any statute, regulation or rule not expressly covered by the release in Paragraph 20 above, including but not limited to any and all of the following claims:

i) State or federal antitrust violations;

ii) Reporting practices, including “best price”, “average wholesale price” or “wholesale acquisition cost”;

iii) Medicaid violations, including federal Medicaid drug rebate statute violations, Medicaid fraud or abuse, and/or kickback violations related to any State’s Medicaid program; and,

iv) State false claims violations.

c. Any liability under the State of Florida’s above-cited consumer protection laws which any person or entity, including Released Parties, has or may have to individual consumers or State program payors of said State, and which have not been specifically enumerated as included herein.
Paragraph 22:

Within ten (10) days of the Effective Date of this Judgment, Merck shall pay a total amount of fifty eight million dollars ($58,000,000.00) to be divided and paid by Merck directly to each Signatory Attorney General in an amount to be designated by and in the sole discretion of the Multistate Executive Committee. Said payment shall be used by the States for attorneys’ fees and other costs of investigation and litigation, or to be placed in, or applied to, the consumer protection enforcement fund, consumer education, litigation or local consumer aid fund or revolving fund, used to defray the costs of the inquiry leading hereto, or for other uses permitted by state law, at the sole discretion of each Signatory Attorney General. . . .

Sincere hat tip -- to Marilyn Mann!

4 comments:

Marilyn Mann said...

Here's my post on the settlement:

http://www.gooznews.com/node/3012

Condor said...

As ever, MM, yours is more cogently-turned than mine. Thanks for leaving the link!

I've added it to teh top of mine, as an update.

Namaste

Yeast Infection said...

Things are moving in the right direction here.

Anonymous said...

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