BEIJING BRUSSELS CHICAGO DALLAS FRANKFURT GENEVA HONG KONG LONDON LOS ANGELES NEW YORK SAN FRANCISCO SHANGHAI SINGAPORE SYDNEY TOKYO WASHINGTON, D.C.

Reprints

Coleen KlasmeierMarch 27, 2008

Development of FDA Policy• Early FDA “enforcement” activity• 1993 WLF files Citizen Petition• 1994 WLF files First Amendment lawsuit in federal court in

D.C.• 1995 FDA issues Draft Guidance, “Dissemination of

Reprints of Certain Published, Original Data” (60 Fed. Reg. 63,384 (Dec. 8, 1995))– Only peer-reviewed, published version of original efficacy trials– Finalized without change (61 Fed. Reg. 52,800 (Oct. 8, 1996))

• FDA: the Guidance “strike[s] the proper balance between the need for an exchange of reliable scientific data and information within the health care community, and the statutory requirements that prohibit companies from promoting products for unapproved uses.”

Development of FDA Policy• 1997 Congress enacts FDAMA § 401

– The article had to be unabridged, peer-reviewed, published in a scientific or medical journal, and about a clinical investigation that would be considered scientifically sound

– FDA’s implementing regulations at Part 99 defined “scientifically sound” and “clinical investigation” to further limit the type of reprint that could be disseminated under FDAMA

– Manufacturer must submit supplemental application for new use

• 1998-99 Judge Lamberth declares both guidance and FDAMA provision unconstitutional– Injunction: FDA could not seek to limit any manufacturer from

giving to medical professionals any article concerning medical devices previously published in a bona fide peer-reviewed professional journal—even if the article includes a significant or exclusive focus on off-label uses; no limitation to original study on which FDA approval was based.

Development of FDA Policy• 2000 WLF litigation concludes ambiguously after the Government

articulates “safe harbor” interpretation– Court of Appeals dismisses the appeal and vacates the district court’s

decisions and injunctions “insofar as they declared FDAMA unconstitutional” but explicitly did not take issue with the district court’s First Amendment analysis

• 2000 FDA issues Federal Register notice purporting to “clarify” agency policies post-WLF (65 Fed. Reg. 14,286 (Mar. 16, 2000))– If a manufacturer “proceeds used” FDAMA and Part 99:

• And “complies,” then FDA may not use the reprints “as evidence that the product is intended to be used for a ‘new use.’

• And “does not comply,” then “FDA may seek to enforce compliance through an injunction action under the FDCA to halt a violation of section 301(z).

– “If a manufacturer does not proceed under Section 401, that failure does not constitute an independent violation of law,” but “FDA may bring an enforcement action . . . and seek to use journal articles . . . disseminated by the manufacturer as evidence that an approved product is intended for a ‘new use.’”

Development of FDA Policy

• 2000 WLF returns to district court, but court explains that entire injunction was vacated– “After six years’ worth of briefs, motions, opinions,

congressional acts and more opinions, the issue remains 100% unresolved, and the country’s drug manufacturers are still without clear guidance as to the permissibility of this conduct.” Washington Legal Found. v. Henney, 28 F. Supp. 2d 11, 15 (D.D.C. 2000).

• 2001 WLF files Citizen Petition requesting that FDA withdraw the March 16, 2000 Notice and in its place issue a policy statement indicating the agency’s adherence to the district court’s decision

Development of FDA Policy• 2002 FDA denies Citizen Petition and further

“clarifies” its position on reprints– Same basic position as March 16, 2000 Federal Register

notice– If distribution of reprints outside the safe harbor “forms

part of the basis” of FDA’s enforcement action, “the trier of fact will consider the context of that activity and any other indicators of independence in assessing the manufacturer’s objective intent.”

– Manufacturer may raise a First Amendment defense in such an enforcement action.

– FDA would be “unlikely to initiate an enforcement action where the only evidence of an unapproved intended use is the distribution of enduring materials . . . “

Current Status• FDAMA § 401 sunset effective Sept. 30, 2006 (Pub. L.

No. 105-115, § 401(e); 63 Fed. Reg. 31,143, 31,145 (June 8, 1998))– Surviving FDA policy unclear

• Does sunsetting effectively “revive” the guidance?• Given FDA’s emphasis on the FDAMA provision in the March

16, 2000, Federal Register notice and the 2002 Citizen Petition response, do those policy statements have any continuing validity?

• ~ 2006-07 FDA determines to develop a new policy document– Draft Guidance published for comment Feb. 20, 2008

(73 Fed. Reg. 9,342)

The Draft Guidance• FDA “recognize[s] the important public policy reasons

for allowing manufacturers to disseminate truthful and non-misleading medical journal articles . . . on unapproved uses of . . . approved or cleared medical devices to healthcare professionals and healthcare entities.” (p. 3)

• The draft does not recognize any other safe harbors– FDA policies

• Responses to unsolicited requests• “Scientific exchange”• Support for “industry-sponsored scientific and educational

events” (e.g., CME)– First Amendment

Resources

• FDA’s Draft Reprints Guidance– via www.regulations.gov; use docket identifier FDA-

2008-D-0053-0001 (NOA, draft guidance, and comments)

– via www.fda.gov• http://www.fda.gov/oc/op/goodreprint.html or

http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0053-gdl.pdf (guidance)

• http://www.fda.gov/bbs/topics/NEWS/2008/NEW01798.html (FDA news release)

– House Comm. on Oversight and Government Reform: http://oversight.house.gov/investigations.asp?id=216