Posted: 24 Jan 2017 01:22 AM PST
By Etan J. Yeshua –
On January 20, 2017, the Trump administration took a first step toward delaying, reconsidering, and potentially undoing numerous regulations and policies issued by the Obama administration. In order to ensure that “the President’s appointees or designees have the opportunity to review any new or pending regulations,” White House Chief of Staff Reince Priebus issued to the heads of executive departments and agencies a memorandum titled “Regulatory Freeze Pending Review.”
The memo first requests that no regulation be sent to the Office of the Federal Register for publication until a Presidential appointee or designee has reviewed and approved it. Second, the memo states that regulations that were sent to the Office of the Federal Register but that have not yet been published in the Federal Register are to be immediately withdrawn, and then reviewed by a Presidential appointee or designee. Lastly, regulations that have been published in the Federal Register but that have not yet taken effect are to have their effective date postponed for 60 days (from January 20, 2017), after which the agency or department is to “consider potentially proposing further notice-and-comment rulemaking” and, if further action is deemed appropriate, “agencies should notify the OMB Director and take further appropriate action in consultation with the OMB Director.”
The freeze applies not only to final regulations but also to notices of proposed rulemaking, guidance documents, and other “substantive action by an agency . . . that is or is expected to lead to the promulgation of a final rule,” as well as to “any agency statement of general applicability and future effect ‘that sets forth a policy on a statutory, regulatory, or technical issue or an interpretation of a statutory or regulatory issue.’” The memo provides exceptions for “emergency situations or other urgent circumstances relating to health, safety, financial, or national security matters,” and for regulations that are subject to statutory or judicial deadlines.
The implications for industry have the potential to be significant and the freeze may provide an opportunity to further engage with agencies and departments and to influence pending rules and policies. For example:
Posted: 23 Jan 2017 10:05 AM PST
By Anne K. Walsh –
It feels like déjà vu. In 2011, FDA announced the establishment of a docket to evaluate its policies on communications and activities related to off-label uses of marketed products; late in 2014, FDA committed to issuing new guidance by the end of 2014 to address “unsolicited requests, distributing scientific and medical information on unapproved new uses, and manufacturer discussions regarding scientific information more generally,” which it did not. Instead, two years after their self-imposed deadline, FDA convened a public meeting to solicit views on these same issues (discussed here). The comment period for that hearing officially closed on January 9, 2017, and although FDA has published two draft guidance documents touching on communications consistent with the approved labeling or related to healthcare economic information (to be discussed in a separate blog post), FDA punted on the critical issue of off-label promotion.
On January 19, 2017, ten days after the comment period closed, FDA reopened the comment period for 90 days (until April 19, 2017). According to FDA, commenters at the November 2016 hearing complained that “FDA had not sufficiently discussed the First Amendment in the notification of public hearing.” 82 Fed. Reg. 6367, 6368 (Jan. 19, 2017). Note that the original Federal Register notice stated FDA solicited comments on “ongoing developments in science and technology, medicine, health care delivery, and constitutional law,” 81 Fed. Reg. 60299, 60300 (Sept. 1, 2016) (emphasis added), and anyone even superficially following these issues understands the First Amendment implications involved. FDA announced that it had prepared a Memorandum to specifically address First Amendment considerations and FDA’s initial reaction to proposed approaches to addressing them, and asked for public comment on the Memo.
The 60-page document is substantively light, as there is much background and rehashing of FDA’s legal authority contained in earlier public statements and briefs. FDA spends considerable time articulating the public health interests affected by communications about unapproved uses. FDA touts its efforts to date as claiming “to strike a careful balance, supporting medical decision-making for patients in the absence of better options, but doing so without undermining the measures designed to incentivize the development and approval/clearance of medical products that would reduce the need to rely on unapproved use, in light of its risks.” FDA Memo, at 20.
In the Memo, FDA describes its view of case law addressing the First Amendment and FDA regulation of off-label communications. Consistent with earlier statements, FDA attempts to limit the Second Circuit ruling in United States v. Caronia by claiming it does not hold that speech cannot be used as evidence of intended use if the misbranding charge is based solely on truthful, non-misleading speech regarding the unapproved use of an approved product. FDA relies on a footnote in a qui tam matter in which the Second Circuit opines about the potential use of promotional speech in an FDA enforcement action, without reference to the truthful or non-misleading nature of the speech. FDA Memo at 22. FDA also undermines the Caronia decision for not taking into account a study published last year that purportedly shows an association between unapproved uses and adverse drug events. Id. at 23-24. It is ironic that FDA relies on a published study to support its position, yet puts significant restrictions on the distribution of similarly credentialed literature by industry.
The meat of the memo is FDA’s identification of alternative approaches to address off-label promotion, and the outright rejection of all of the approaches. They include:
martes, 24 de enero de 2017
FDA Law Blog: Winter Freeze Descends on Nation’s Capital
FDA Law Blog: Winter Freeze Descends on Nation’s Capital