Archive for the ‘Health Care Industry’ Category

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The FDA released draft guidance last week which should prove helpful to pharmaceutical manufacturers, marketers and communicators. The draft guidance, Unsolicited Requests for Off-Label Information about Prescription Drugs and Medical Devices, addresses questions received by consumers around off-label drug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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Posted in FDA, Health 2.0, Health Care Industry
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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FDA’s guidance documents, including this draft guidance, do not establish legally enforceable rights or responsibilities.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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Posted in FDA, Health 2.0, Health Care Industry
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LukeDickinson
Luke
Dickinson

Decision 2012 – Presidential Candidates on Health Care

Tuesday, December 20th, 2011

Across early primary states Republican Presidential candidates are fighting tooth and nail to appeal to voters in the hope of becoming the next President of the United States of America.

While prime-time pundits may revel in polling data, “zany” tactics or the latest campaign trail gaffe, serious voters remain concerned with the issues. The economy has become the hot topic for the cycle, but with Democrat-led health care reforms still riling many Republicans, voters are paying close attention to the candidates’ stance on health care.

The overarching message from each and every candidate is dire need to “repeal Obamacare.” Republicans argue that “Obamacare,” the Affordable Care Act passed by President Obama in March of 2010, does little to improve health care quality while simultaneously restricting individual freedoms through requirements to purchase health insurance. If elected, each major Republican candidate would repeal “Obamacare.” But where will each candidate go from there?

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Posted in Health Care Industry, Health Care Reform, Health Policy, Public Affairs, SCOTUS, SCOTUS Beat
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Anthony LaFauce
Anthony
LaFauce

Where Are We Going?

Thursday, November 17th, 2011

Yesterday Maggie Fox (@maggiemfox) wrote a great piece regarding an American Heart Association study about the current trend in obesity and the health of Americans. The piece was based on a 10 year study that looked at the trending health and weight issues we face. The study lists a series of issues America will face due to this epidemic. I use the term epidemic because things like increases in high blood pressure, diabetes and of course heart diseases are forcing us into a national crisis.

When everyone hears about health issues the cost of health care becomes top of mind. When I do, and I’m sure as an Air Force brat, when Maggie does as well, it also brings national security and national resources to mind. Over a quarter of all young adults between the age of 17 and 24 are physically unfit to serve. I know a percentage of those people have physical reasons why they can’t serve but the number is still staggering. As a former United States sailor it absolutely shakes me to the core to think of what will happen if this trend in Americans’ health continues.  Will we not be able to protect our borders, man our ships or send humanitarian aid to countries when they have natural disasters like typhoons or earthquakes?

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Posted in Chronic Disease, Community Involvement, Disease Awareness, Health 2.0, Health Care Industry
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LukeDickinson
Luke
Dickinson

SCOTUS Beat: Review of Health Care Reform Heats Up

Friday, October 28th, 2011

The highly anticipated Supreme Court review of landmark health care reform legislation has taken a step closer to reality. The nine Supreme Court Justices announced on Oct. 26 that they will review five of six pending petitions on Nov. 10, one of their closed-door conference days.

In this session, the Justices will decide whether or not to hear any or all of the petitions that challenge the massive Patient Protection and Affordable Care Act (ACA), spearheaded by the Obama administration. While it is not guaranteed that the petitions will come before the court, legal experts anticipate that the Justices will take on this controversial topic, notably as lower federal appeals courts have previously made divergent rulings on the constitutionality of the new law.

So just what are these petitions? Four of the five to be reviewed on Nov. 10 are challenges to the ACA, with the fifth presented by the federal government to defend the constitutionality of key elements of the act. A sixth petition, which is not yet ready to be presented to the Justices, examines the rights of states, specifically Virginia, to challenge the federal government in court.

The most contentious element that the Court may decide is whether Congress exceeded its authority by mandating that virtually all Americans purchase health insurance by 2014. Also up for possible review is whether new Medicaid requirements place too great a strain on the states. Further, if the Justices rule that the individual mandate is indeed unconstitutional, they must determine whether this invalidates the entire ACA or whether parts of it can remain enacted.

The decision of the Court on whether or not to hear these cases could come very quickly, either the day of the conference or the following Monday, Nov. 14. If the Court does, as anticipated, decide to hear the cases, it is more than likely they will be heard in the current term, with possible oral arguments coming in March 2012, with a decision as early as June 2012.

Lawyers, law makers, health care providers and individual citizens will be waiting with baited breath for the decision of the Supreme Court Justices. There is a great deal at stake for all parties on the potential decision of the Court, from the rights of patients and providers to statewide Medicare and Medicaid budgets, and potentially even the outcome of the 2012 Presidential election. Rest assured, the Full Spectrum Blog will be tracking the court every step of the way to keep our readers up-to-date.

Posted in Health Care Industry, Health Care Reform, Health Policy, Public Affairs, SCOTUS, SCOTUS Beat
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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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