For The Defense, December 2011 - DRI Today

More documents

Recommendations

Info

dRug and MedIcaL devIce FDA Regulation By Michael A. Walsh Recent First Amendment rulings usher in a fresh look at the rules governing off-label communications. ■ Michael A. Walsh is a partner in the Dallas office of Strasburger & Price and leads the firm’s Drug and Device Industry Team. He devotes most of his practice to representing clients in FDA regulated industries on issues related to labeling, and is a member of the DRI Drug and Device Committee and the Laws and Regulations Committee of the Association of Food and Drug Officials. 40 ■ For The Defense ■ December 2011 Off-Label Promotion and the First Amendment Warning: The reader is forewarned that [off-label promotion] is like a swamp laced with land mines; do not venture into this new claims- dissemination process without very great caution and attention to detail.
James T. O’Reilly, Food and Drug Administration §15:46 (Thompson Reuters/West, 3rd ed. 2009). The Food and Drug Administration’s efforts regarding off- label use of medical products have resulted in a patchwork of regulations, guidance documents, statements, prosecutions, letters, and consent decrees that significantly restrict manufacturers from communicating concerning off- label uses. The restrictions hold true even when the “off- label” use constitutes the standard of care in practicing medicine and is based on truthful, sound science. The data show that doctors widely prescribe medical products for off- label use and that they need more, not less, information. While it is recognized that manufacturers of medical products are most knowledgeable about their products and best situated to participate in a dialogue with physicians regarding off- label use, they do so in a murky regulatory world in which the penalty for missteps is state or federal criminal proceedings and potentially crippling fines. We are in a unique time when the regulatory framework is intersecting with resurgence in First Amendment jurisprudence, which very well may result in courts taking a fresh look at the regulatory scheme governing off- label communications. Congress established the Food and Drug Administration (FDA) and set its mission to promote the public health and to ensure that drugs and devices are safe and effective. 21 U.S.C. §393. And as explained in the 1970s, “the major objective of the drug provisions of the Federal Food, Drug, and Cosmetic Act is to assure that drugs will be safe and effective for use under the conditions of use prescribed, recommended, or suggested in the labeling thereof.” Legal Status of Approved Labeling for Prescription Drugs, 37 Fed. Reg. 16,503 (Aug. 15, 1972). Off-Label Use and New Use “Off-label use” is when, in exercising professional judgment in the practice of medicine, a physician uses a product for an indication, dosage or duration not in the FDA approved labeling. “New use” and “new drug or device” are terms that the FDA uses when a manufacturer communicates concerning an “off- label use.” The FDA views disseminating information relating to a “new use” for a drug or device that it has not approved as “labeling,” and evidence of a new “intended use” that renders the drug or device adulterated or misbranded. 21 C.F.R. §99.405. Misbranding A product is “misbranded” if the “labeling” includes a statement that is “false or misleading in any particular.” 28 U.S.C. §352(a); see also 28 U.S.C. §321(n) (statements and omissions may make a statement false or misleading). A product also is considered misbranded if the labeling lacks “adequate directions for use.” 28 U.S.C. §352(f)(1). In prosecuting off- label promotion, the government has taken the position that any “suggest[ion] that [a] drug is safe and effective” for an off- label use is “false or misleading,” irrespective of the scientific support for the suggestion. U.S. v. Warner- The medical profession recognizes off- label use as appropriate in the practice of medicine. Lambert Co, LLC, No. 04-10150 RGS, at 8–9 (D. Mass. June 2, 2004) (Warner- Lambert Sentencing Memo); 21 U.S.C. §352(a). To determine misbranding, the FDA inquires whether product labeling possesses adequate information “for the purposes for which [the product] is intended, including all purposes for which it is advertised or represented.” 21 U.S.C. §352(f)(1). The FDA defines a drug’s “intended uses” to include FDA- approved on- label uses and any use “objective[ly] inten[ded]” by the manufacturer. 21 C.F.R. §201.128. A manufacturer may show its “objective intent” by an expression in labeling, an advertisement, or other “oral or written statements.” Id. If, with the knowledge of the manufacturer, the drug is “offered and used for a purpose for which it is neither labeled nor advertised,” that constitutes “objective intent” as well. Id. If a manufacturer “knows, or has knowledge of facts that would give notice” that its drug “is to be used” off- label, it “is required to provide adequate labeling for such a drug which accords with [those] uses.” 21 C.F.R. §201.128 (emphasis added). The FDA and the Practice of Medicine Congress elected not to permit the FDA to interfere with the discretion or decision- making of physicians caring for and treating patients: “Nothing in [the Federal Food, Drug & Cosmetic Act] shall be construed to limit or interfere with the authority of For The Defense ■ December 2011 ■ 41
Page 2 and 3: Complex Claims Require Expert Knowl
Page 4 and 5: DRI—The Voice of the Defense Bar
Page 6 and 7: DRI Services 55 West Monroe Street
Page 8 and 9: DRI ToDay— The NexT 50 yeaRs 2011
Page 10 and 11: Embracing Our Common Humanity— Pr
Page 12 and 13: Scalia and Garner: Making Your Case
Page 14 and 15: Transportation Security— Its Evol
Page 16 and 17: The Awards This year during the DRI
Page 18 and 19: plan committed to achievement, sens
Page 20 and 21: National Conclave of State and Loca
Page 22 and 23: Over Criminalization of Business Co
Page 24 and 25: 22 ■ For The Defense ■ December
Page 26 and 27: pRoFessIonAl lIAbIlITy Sidestepping
Page 28 and 29: PROducT LIabILITy Past Is Prologue
Page 30 and 31: Product LiabiLity specific faciliti
Page 32 and 33: Product LiabiLity the two types of
Page 34 and 35: Product LiabiLity sive, albeit inco
Page 36 and 37: Professional liability The Times Th
Page 38 and 39: Professional liability ity of those
Page 40 and 41: Professional liability policies exc
Page 44 and 45: Drug anD MeDical Device a health ca
Page 46 and 47: Drug anD MeDical Device the manufac
Page 48 and 49: Drug anD MeDical Device “mere bee
Page 50 and 51: TRuckIng Law From the Chair By Kurt
Page 52 and 53: Trucking Law Rapid Response Teams B
Page 54 and 55: Trucking Law important way to docum
Page 56 and 57: Trucking Law there is no way to kno
Page 58 and 59: Trucking Law sonally witnesses an a
Page 60 and 61: Trucking Law A driver’s refusal t
Page 62 and 63: Trucking Law the likely attitudes o
Page 64 and 65: Trucking Law aging juror responsive
Page 66 and 67: Trucking Law Cross-border trucking
Page 68 and 69: Trucking Law Wake-Up Call for Carri
Page 70 and 71: Trucking Law den of proof standard
Page 72 and 73: Trucking Law The court concluded th
Page 74 and 75: Trucking Law share some of her know
Page 76 and 77: Trucking Law formula and are also n
Page 78 and 79: Trucking Law Intervention and “No
Page 80 and 81: Writers’ Corner Social Proof Why
Page 82 and 83: ThInk gLObaLLy 10 Tips Obtaining Ev
Page 84 and 85: Attorneys defending motor carriers
Page 86 and 87: FMSCa evaluation, from page 77 Smit
Page 88 and 89: may decide that failing to take thi
Page 91 and 92: Pennsylvania Bonnie S. Stein, Morri

For The Defense, December 2011 - DRI Today

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?