Big pharma objects to new hurdles for off-label drug, device promotion _ bloomberg bna

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Big Pharma is challenging a final rule that affects the off-label promotion of drugs

The Food and Drug Administration in the final rule revised the definition of “intended

use” to include a new “totality of the evidence” standard that wasn’t in the proposed

Because stakeholders weren’t given fair notice of the revision and opportunity to

comment, the FDA violated the Administrative Procedure Act (APA), three industry groups—the

Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry

Organization (BIO) and the Medical Information Working Group (MIWG)—said in a Feb.

The intended uses of a product determine whether the product is regulated as a drug

or device by the FDA, and they are described in the product’s labeling. Health information websites Doctors can

prescribe products for off-label uses, but manufacturers can’t promote their products

for off-label uses. What is health care information If they do, they can face enforcement action by the agency.

Some attorneys agree the FDA violated the APA when it made the change to the final

rule. Health information systems management But a consumer group says the change wasn’t a violation and the final rule is

The industry groups said in the petition the FDA should indefinitely stay the final

rule, reconsider it and use a final definition of “intended use” that is consistent

rule (RIN:0910-AH19), published in the Jan. Interoperability of health information systems 7 Federal Register (82 Fed. What is health information exchange Reg. What is a health information manager 2,193), also

describes when a product made or derived from tobacco intended for human consumption

will be subject to regulation as a drug, device or a combination drug/device product

under the Federal Food, Drug and Cosmetic Act. Health information services The rule’s effective date was Feb.

8, but the FDA postponed it until March 21 in a Feb. Health information exchange hie 7 Federal Register

The FDA has 180 days to respond to a citizen petition, but the agency can respond

by saying it is still considering the issue, Bradley Merrill Thompson, a Washington-based

attorney with Epstein Becker & Green PC, told Bloomberg BNA in a Feb. Health management information system hmis 10 e-mail. Health and disease information “So

the deadline really isn’t terribly effective,” he said. Information about health insurance Thompson counsels medical

device, drug and combination-product companies on a wide range of FDA issues.

In the proposed rule, the FDA deleted from the “intended use” definition a provision

that said if a manufacturer has knowledge that a drug or device is used for off-label

conditions, the manufacturer is required to provide adequate labeling for that use.

But in the final rule, the FDA replaced that provision with languages saying it would

consider “the totality of the evidence” when deciding whether a company needs to provide

The petition said that under a totality of evidence standard, “everything may be considered

to establish a product’s intended use. Masshealth information This standard would allow FDA to rely even

on non-promotional scientific exchange as evidence of intended use” and could include

clinical practice guidelines and a company’s response to unsolicited requests for

“There is no support in existing law for the totality standard, and it would represent

a substantial change with significant constitutional and public health ramifications,”

Anne K. What is health information Walsh, an attorney with Hyman, Phelps & McNamara PC in Washington, told Bloomberg

BNA Feb. Information about health and fitness 13 the totality of evidence standard “it’s clear to me that FDA tried to

avoid the notice and comment requirements of the APA,” Walsh said.

Walsh said the petitioner’s APA argument “is certainly strong enough that they could

have filed directly with the court and challenged it on an APA basis.” Walsh counsels

clients on compliance and enforcement issues, including FDA inspections, seizure and

Deborah M. Types of health information systems Shelton, a partner in the FDA Practice Group of McCarter & English in Washington,

told Bloomberg BNA Feb. Reliable health information 13 the FDA “is saying [in the final rule] it’s not the knowledge

but that could be part of the equation and could go into the totality of evidence.”

“The petitioners have a very strong argument that this is actually a change in position

from the proposed rule. Patient health information To do that in the final rule without providing an opportunity

for comment, is arguably violative of the APA,” Shelton said.

Shelton said “whatever the standard is, it’s certainly not what was in the proposed

rule and it’s certainly not what stakeholders had an opportunity to comment on in

2015. What is health information systems And then you have to add to that the complications due to the fact that FDA

and industry are in the middle of this dialogue about off-label communications and

“So, it’s inappropriate content-wise and timing-wise,” and “I think it makes good

In November 2016, the FDA held a public hearing to obtain input about its policies

on manufacturer communications concerning communication about off-label uses of their

). Health information systems jobs The agency also opened a docket to obtain written comments after the hearing (Docket

No. Information about health FDA-2016-N-1149). Unitedhealth group information Comments to the docket were initially due Jan. Health information systems definition 9, and the FDA

Michael Carome, director of Public Citizen’s Health Research Group, told Bloomberg

BNA Feb. Health related information 13 that he doesn’t think the FDA violated the APA in making the change in

“We don’t think there’s anything unique there that’s inconsistent with the existing

The proposed rule struck the last sentence of the definition of “intended use,” which

said “that if a manufacturer knows that a drug or device is being used for off-label

uses such knowledge would require the manufacturer to update the labeling for that

use,” Carome said. Health education information “And when we saw that proposal, we agreed that change seemed reasonable.”

Manufacturers shouldn’t have to update the labeling of their products just because

Carome said the final rule still basically deletes what was in the last sentence of

the definition and replaces it with something else that just clarifies what the FDA

“So we think that new last sentence [in the final rule] addresses the concern that

was originally raised about the sentence and simply clarifies in a different way language

To contact the reporter on this story: Bronwyn Mixter in Washington at

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