Archive for the ‘FDA’ Category

Donald C.
McLearn

Facing Recalls: Rules of the Road for Effective Communication

Monday, February 13th, 2012

Last Friday we looked at some of the circumstances that have led to the recent influx in FDA recalls. But what this conversation really begs is some examination of how we can approach the situation as communicators.

After years of working with manufacturers as they deal with recalls, I thought I would share the top five tips you may find helpful.

  1. Do not assume that quality or compliance issues will never reach the recall stage. Once a device is on the FDA’s radar, it is not likely to fade away. In this day and age, it is more appropriate – and helps companies to be ever ready – to assume that a recall is imminent.
  1. Be patient. These situations are more akin to marathons than sprints. They will not necessarily be resolved in a matter of days or weeks, but more likely months or even years. Settle in for a long haul.
  1. Be as open, transparent and responsive in all communications with the agency as possible.
  1. Communicate frequently with customers and other stakeholders. Keep them informed as to how you are assessing any problems. Reach out to them proactively and respond to their inquiries quickly and efficiently.
  1. Ensure that your employees, at all levels, are informed as well. In particular, keep your sales force and those working on the “front lines” with customers up to speed on the situation and have the tools and resources they need to communicate.

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Posted in FDA, Health Care Industry, Medical Devices
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Donald C.
McLearn

Why Have FDA Recalls Sky-Rocketed Lately?

Friday, February 10th, 2012

According to trade press and the Food and Drug Administration (FDA), the number of high-risk Class 1 medical device recalls skyrocketed to the highest point ever in 2010, nearly doubling from 23 in 2009 to 51 in 2010, a 122 percent increase.

Class 1 is FDA’s most serious recall category, reserved for situations where the agency believes patients face a reasonable probability of serious injury or death. Years ago, when I was in FDA’s Public Affairs Office, there were only a handful of Class 1 recalls for the entire agency in a year. In contrast, in 2010, Bectin Dickinson and Cardiac Science tied for having the most Class 1 recalls with three each.

Back in the day, the Class 1 recalls that did arise were usually tied to fatalities. Take for instance, the Bjork–Shiley heart valve which became the subject of a famous lawsuit and recall after it was shown to malfunction with dire results. Today, there are many different scenarios in which a Class 1 recall may occur.

What could have caused this astronomical growth in Class 1 recalls? There are differing viewpoints. Having spent more than 17 years at the FDA, and many years since consulting with manufacturers on their interactions with the agency, I see several factors coming into play here.

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Posted in FDA, Medical Devices, Public Affairs, Public Health
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LukeDickinson
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
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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LukeDickinson
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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Posted in Biotechnology, Community Involvement, Crisis Management, FDA, Health Care Industry, Medical Devices, Pharma
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