A Murky Future for Off-label Promotion: States vs. FDA - Arizona to Allow Pharma Companies to Legally Communicate Off- Label Treatment Options
This article not only discusses the Arizona bill but also outlines some factors that may help us to understand where the landscape is heading on this issue.
As many of our readers know all too well, pharmaceutical companies are not permitted to discuss off-label, legal, alternative uses for an approved drug with physicians and other healthcare professionals as regulated by the FDA. However, in Arizona, The Free Speech in Medicine Act, recently passed the State of Arizona House of Representatives unanimously.
On March 21, 2017, Governor Doug Ducey signed the bill into law, lifting the aforementioned off-label promotion ...
Source: Policy and Medicine - August 30, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
After a Quiet Summer, Congress Starts Probe into MS Drugs
Congress has recently taken a few months off from constantly barraging the pharmaceutical industry with daily probes and negative news. However, on Thursday, August 17, 2017, Representatives Elijah Cummings of Maryland and Peter Welch of Vermont announced a probe into multiple sclerosis (MS) drug costs, focusing on pricing from seven different pharmaceutical companies, starting with letters to those companies.
Cummings and Welch are asking Bayer, Biogen, Serono (Merck KGaA), Novartis, Sanofi, Teva, and Roche for details about their pricing, focusing on the reasons behind price increases over the past several years. Teva l...
Source: Policy and Medicine - August 30, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
A Murky Future for Off-label Promotion: States vs. FDA - Arizona to Allow Pharma Companies to Legally Communicate Off- Label Treatment Options
This article not only discusses the Arizona bill but also outlines some factors that may help us to understand where the landscape is heading on this issue.
As many of our readers know all too well, pharmaceutical companies are not permitted to discuss off-label, legal, alternative uses for an approved drug with physicians and other healthcare professionals as regulated by the FDA. However, in Arizona, The Free Speech in Medicine Act, recently passed the State of Arizona House of Representatives unanimously.
On March 21, 2017, Governor Doug Ducey signed the bill into law, lifting the aforementioned off-label promotion ...
Source: Policy and Medicine - August 30, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
After a Quiet Summer, Congress Starts Probe into MS Drugs
Congress has recently taken a few months off from constantly barraging the pharmaceutical industry with daily probes and negative news. However, on Thursday, August 17, 2017, Representatives Elijah Cummings of Maryland and Peter Welch of Vermont announced a probe into multiple sclerosis (MS) drug costs, focusing on pricing from seven different pharmaceutical companies, starting with letters to those companies.
Cummings and Welch are asking Bayer, Biogen, Serono (Merck KGaA), Novartis, Sanofi, Teva, and Roche for details about their pricing, focusing on the reasons behind price increases over the past several years. Teva l...
Source: Policy and Medicine - August 30, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
A Murky Future for Off-label Promotion: Off-Label Bills Garner Minimal Traction in Congress
Further muddying the off-label waters is the fact that Congress has introduced several bills, attempting to legislate off-label use. Both bills were initially introduced as attachments to the FDA reauthorization bill, but when House Democrats resisted, both sponsors pulled the bills as attachments. On July 12, 2017, the Subcommittee on Health held a brief hearing on both bills, giving industry and others a chance to speak on off-label promotion.
In March 2017, the United States Food and Drug Administration (“FDA”) delayed a rule that would have expanded its ability to police off-label use for one year. With all of the...
Source: Policy and Medicine - August 29, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Industry Responds to Communication Guidances
In early 2017, FDA issued draft question and answer documents detailing how drug and device firms can discuss unapproved medical products with payers in ways that are "truthful and non-misleading," as well as in ways that are consistent with the FDA-required labeling. Industry offered many comments on the draft guidances outlining the FDA’s policies on industry communications with payers and claims that are on a drug’s label. We note a number of interesting comments from the Federal Register docket:
Comments
In BIO’s comments, the trade association points out:
“While there are many sources of clinical and scient...
Source: Policy and Medicine - August 29, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
A Murky Future for Off-label Promotion: Off-Label Bills Garner Minimal Traction in Congress
Further muddying the off-label waters is the fact that Congress has introduced several bills, attempting to legislate off-label use. Both bills were initially introduced as attachments to the FDA reauthorization bill, but when House Democrats resisted, both sponsors pulled the bills as attachments. On July 12, 2017, the Subcommittee on Health held a brief hearing on both bills, giving industry and others a chance to speak on off-label promotion.
In March 2017, the United States Food and Drug Administration (“FDA”) delayed a rule that would have expanded its ability to police off-label use for one year. With all of the...
Source: Policy and Medicine - August 29, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Industry Responds to Communication Guidances
In early 2017, FDA issued draft question and answer documents detailing how drug and device firms can discuss unapproved medical products with payers in ways that are "truthful and non-misleading," as well as in ways that are consistent with the FDA-required labeling. Industry offered many comments on the draft guidances outlining the FDA’s policies on industry communications with payers and claims that are on a drug’s label. We note a number of interesting comments from the Federal Register docket:
Comments
In BIO’s comments, the trade association points out:
“While there are many sources of clinical and scient...
Source: Policy and Medicine - August 29, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
A Murky Future for Off-label Promotion: New Leadership at the FDA Brings Change
On May 11, 2017, Dr. Scott Gottlieb was sworn in as the U.S. Food and Drug Administration’s latest Commissioner. Since that time, there has already been various regulatory changes and shifts, in terms of policy guidance, as well as a new focus toward easing the Agency’s rules and regulations pertaining to off-label uses. The article will explore those changes and the Agency continues to refine the “intended use” rules.
The U.S. Food and Drug Administration’s (“FDA”) Twenty-Third Commissioner, Dr. Gottlieb, is a man of many talents. He is a physician, medical policy expert, and public health advocate. As a pr...
Source: Policy and Medicine - August 28, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Is FDA Building its Talent Pool?
We recently reported on the Senate’s passage of the FDA Reauthorization Act (FDARA) which renews and enhances the FDA drug, medical-device, biosimilar, and generic-drug user-fee provisions. Without these fees, FDA was expected to issue employee layoffs, but FDA Commissioner Scott Gottlieb informed agency employees via email on July 24th that he would not be sending out any layoff notices to user fee-funded staff “unless and until September 30 had passed without reauthorization.” We now have an interesting story that outlines how the FDA plans to build—rather than layoff—its talent pool.
FDA Recruiting Talent
Ac...
Source: Policy and Medicine - August 28, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
A Murky Future for Off-label Promotion: New Leadership at the FDA Brings Change
On May 11, 2017, Dr. Scott Gottlieb was sworn in as the U.S. Food and Drug Administration’s latest Commissioner. Since that time, there has already been various regulatory changes and shifts, in terms of policy guidance, as well as a new focus toward easing the Agency’s rules and regulations pertaining to off-label uses. The article will explore those changes and the Agency continues to refine the “intended use” rules.
The U.S. Food and Drug Administration’s (“FDA”) Twenty-Third Commissioner, Dr. Gottlieb, is a man of many talents. He is a physician, medical policy expert, and public health advocate. As a pr...
Source: Policy and Medicine - August 28, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Is FDA Building its Talent Pool?
We recently reported on the Senate’s passage of the FDA Reauthorization Act (FDARA) which renews and enhances the FDA drug, medical-device, biosimilar, and generic-drug user-fee provisions. Without these fees, FDA was expected to issue employee layoffs, but FDA Commissioner Scott Gottlieb informed agency employees via email on July 24th that he would not be sending out any layoff notices to user fee-funded staff “unless and until September 30 had passed without reauthorization.” We now have an interesting story that outlines how the FDA plans to build—rather than layoff—its talent pool.
FDA Recruiting Talent
Ac...
Source: Policy and Medicine - August 28, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
5th Annual Promotional Review Committee Compliance & Best Practices
ExL Events is hosting the 5th Annual Promotional Review Committee Compliance & Best Practices conference on October 16–17, 2017 at the Wyndham Hamilton Park in Florham Park, NJ.
Promotional review professionals have been challenged by many new regulatory developments in the last four years, due to the rapid growth of social media as a marketing platform, the popularization of online regulatory submission, and the still-growing shockwaves from 1st Amendment court decisions about off-label communication.
This year’s conference convenes industry experts from AbbVie, Allergan, Daiichi Sankyo, Eli Lilly, Leo Ph...
Source: Policy and Medicine - August 25, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
FDA Considering Removing Regulatory Obstacles to Generic Competition
Mid-July 2017, the United States Food and Drug Administration held a public meeting to discuss options and steps to encourage innovation in drug development and accelerate consumer access to generic drugs. FDA believes that attempting to strike such a balance will speak to Congress’ initial intent when it enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments).
FDA Commissioner Scott Gottlieb opened the meeting with a discussion of the Agency’s position and the announcement of the intended 2017 release of two new documents to improve the generic approval ...
Source: Policy and Medicine - August 25, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
15th Annual Independent Medical Education and Grants Breakthrough Summit
The Fifteenth Annual Independent Medical Education and Grants Breakthrough Summit will be held September 12 through 13, 2017 at the Sonesta Hotel in Philadelphia, Pennsylvania. The event promises to bring together supporting organizations, medical education providers, and other key stakeholders to address some of the industry-leading issues.
Attendees will gain the latest insights on how to: assess the opportunities for medical education in a value-based healthcare landscape; evaluate and weigh the benefits versus costs to incorporate innovative learning formats and the latest technologies into CME; partner with patient a...
Source: Policy and Medicine - August 24, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
