Posts Tagged ‘FDA’

Luke
Dickinson

Why I like the FDA’s New Draft Guidelines

Thursday, January 5th, 2012

The FDA released draft guidance last week which should prove helpful to pharmaceutical manufacturers, marketers and communicators. The draft guidance, Unsolicited Requests for Off-Label Information about Prescription Drugs and Medical Devices, addresses questions received by consumers around off-label drug or medical device use. It makes clear that manufacturers are able to provide information to requests on off-label uses, received both on- and off-line, without falling foul of regulations.

The draft guidelines allows for companies to respond to unsolicited requests for information on off-label use that are posted by consumers on public forums – including social media, websites, online forums, and in-person public events and meetings – as well as questions received in a non-public medium – via direct email, letter, phone call or fax. The key is that these must not be solicited questions, defined as any inquiry which results from one of eight possible scenarios or prompts led by the manufacturer.

The FDA advises that any response made to an unsolicited question must a) be made directly to the individual posing the question, and b) must only address the specific questions posed.

This means that even if an individual posts a question on off-label use to a company’s public Facebook wall, the company can only respond directly to that individual (via email, phone or letter) not publically to the post. The most that can be posted publically is information on how an individual can directly contact the company to have their specific question privately addressed.

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Anthony
LaFauce

Why I dis-like the FDA’s New Draft Guidelines

Thursday, January 5th, 2012

After reading the FDA’s ‘guidance’ I really have to say I am not impressed with this effort. To be honest it looks like a cookie cutter response to questions our industry has had for the past 4 years. I am truly moved by the fact the FDA opened with a disclaimer stating that the guidance provided was not the end-all-be-all to help communicators communicate.

FDA’s guidance documents, including this draft guidance, do not establish legally enforceable rights or responsibilities.

The document has some difficult to digest information regarding the difference between “non-public” and “public”. This means that the document fails to address if information is shared with a patient in a non-public area and that information becomes public. This is very disturbing if you consider the FDA’s guidance that information should be pushed to off label users in ‘private’ communication tools.

The document also has a small example, in line 189, which focuses on how information of a medical nature is presented to potential patients while on a website. The guidance suggests if a website talks about a various disease or condition AND includes items located in a header or menu that a refers to another disease condition a person can misconstrue this as a company endorsing a products use and the company is at fault.

If a firm sets up a website that enables viewers to read prepared standard responses for the firm’s products that are generated from prefixed pull-down menus naming various disease states, including any standard responses related to off-label uses for the firm’s product, resulting requests for off-label information would be considered solicited. Moreover, if this website makes it possible to use search terms to generate standard responses that go beyond the scope of the product information being requested, including off-label use information, resulting requests for and responses to such a search would be considered solicited requests.

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Luke
Dickinson

Medical Device Recall and Crisis Response

Tuesday, October 25th, 2011

There have been countless recalls of faulty drugs and medical devices in the pharmaceutical and device industry. Some have been the result of malicious actions by external parties, while others can be attributed to production faults or other random incidents. No matter what the cause, the manufacturer is always placed directly in the spotlight and how they respond can have lasting effects on their reputation.

The most recent to capture the media’s attention – as they inevitably always do – is a voluntary recall of around 600,000 contact lenses made by New York-based CooperVision, Inc. Federal health officials claim that an “undefined residue” on the lenses has caused a range of eye problems, from blurred vision to painful corneal tears.

CooperVision has come under heavy criticism for their slow response to the recall. This delay has resulted in threats by the FDA to issue a public health warning and sweeping negative media coverage for CooperVision. As a voluntary recall, the Food and Drug Administration, which regulates contact lenses as a class III medical device, has only limited authority to force CooperVision into action, with much of the onus for notification and action placed on the individual retailers.

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Kelly
Barrett

Five Common Sense Tips for Pitching Bloggers

Monday, October 24th, 2011

For a blogger-turned-PR-professional, there is really no feeling quite so sad (and comical), as receiving a seriously awful pitch email. You know ‘em when you see ‘em. They sometimes start out with “I found your blog, [insert full URL of blog] and truly enjoyed reading [insert arbitrary post], as well as [insert other arbitrary post].” They then go on to talk about an “opportunity” for you to cover something that’s really not vaguely connected to either of the two posts that they called out. I used to blog about cooking and sustainable agriculture, and once got a pitch about organic carpeting. That sort of thing.

I’m not saying that pitching a blogger is easy. It’s an art, and it’s foreign to many of today’s PR professionals rooted in more traditional outreach. As evidence of this challenge, we’ve been seeing all sorts of PR blogger pitching flubs arising in the news lately. And they go beyond just the run-of-the-mill boring pitch. Some of my personal favorite headlines include:

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Kelly
Barrett

BDI’s Social Communications & Healthcare 2011: Empowering employees to ‘play’ with social media

Tuesday, July 19th, 2011

Last Wednesday, I had the pleasure of attending the Business Development Institute’s Social Communications & Healthcare conference in New York City. It was the third year that BDI has put on the conference but one of the first times the event has included such robust case studies from industry leaders.

It is unfortunate that in pharma, we really don’t have many social media case studies to look at, yet. And this isn’t just because social media is new, because really, it’s not that new anymore (and what’s new today is old tomorrow). The problem lies more in the fact that so many companies and agencies are doing innovative stuff that they aren’t yet allowed to disclose. Here at Spectrum, a number of our progressive social media-related initiatives are highly sensitive and stay confidential. However, in the meantime, it’s inspiring to see all the ways people are finding to best socially communicate.

BDI Wrap Up from Zemoga on Vimeo.

(Pixels & Pills covered the event and they provide a ton of great video interviews that you should check out. And New Millenium Research & Consulting has photos up on their Facebook.)

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Ricki
McCarroll

FDA beats out European Counterpart in Oncology Drug Approval

Thursday, June 16th, 2011

The FDA is proving to be a top contender in the international space in its efforts to fight the battle on the Big C, yes we’re talking cancer.

Source: Friends of Cancer Research Study

A new study released online today by Friends of Cancer Research in Health Affairs reports that the U.S. Food and Drug Administration (FDA) has a faster approval rate for oncology drugs than their European counterpart agency, the European Medicines Agency (EMA).

The study was held over a seven year period beginning 2003 through 2010. Authors Samantha A. Roberts, Jeff D. Allen, and Ellen V. Sigal investigated 35 drugs going through approval process in both markets and compiled their results in an eight-page report complete with graphics and pull quotes.

FDA v. EMA Stats

  • 35 drugs were investigated
  • FDA approved 32 oncology drugs while the EMA approved only 26
  • In addition, FDA’s approval for said drugs was over 31 percent more time efficient that the EMA

Statistically speaking, the approval ratio is less than one.

Finding the data

Authors of the study utilized public data bases on the FDA and EMA websites to conduct their research. Drugs used in the study are direct oncology treatments, drugs related to “supportive care” such as pain relievers and anti-nausea medications were omitted in their findings.

Check it Out

The Friends of Cancer Research study is currently available online and will be available in the July issue of Health Affairs.

What’s the spark under the FDA?

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