Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Need a Guidance Document? FDA's Dynamic Search Has You Covered - If It Exists :)

Need a Guidance Document? FDA's Dynamic Search Has You Covered - If It Exists :) | Pharmaguy's Insights Into Drug Industry News | Scoop.it

We all understand the frustration of searching online for something and not finding it. The Food and Drug Administration recently helped end this problem by making it faster and easier to find our guidance documents—some of the most requested items on our website.


Guidance documents represent FDA’s current thinking on a particular subject. Currently, there are about 3,100 of them – and the list is growing.

FDA’s Web & Digital Media team and the Office of Information


Management and Technology have created a dynamic search list on one site so you can go to just one page and find the guidance documents you need, no matter where they are on FDA.gov. This search tool is powerful and easy to use. Now you can go to just one search box to find what you need in moments, instead of the 10 different pages on FDA’s website where guidance documents are posted.


It doesn’t matter if it’s a guidance document on devices, drugs, biologics, tobacco, veterinary medicine, or foods – it’s all there.


We did this as part of FDA’s Transparency Initiative and in response to the feedback we got from our stakeholders via the American Customer Service Index (ACSI) online survey. They told us just how hard and time-consuming it was for them to find these important documents. So we decided to do something about it.


Pharma Guy's insight:

Perhaps FDA can help you find guidance documents that EXIST, but what pharma really needs are guidance documents that do not yet exist but that are long-promised, such as critical social media guidance documents.

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FDA Off-Label Guidance Puts Patients at Risk, Says Public Citizen

FDA Off-Label Guidance Puts Patients at Risk, Says Public Citizen | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Ninety-nine percent of people or organizations that commented on a government proposal to allow the drug industry to misinform doctors about potential risks of medications oppose the plan, a Public Citizen analysis shows.

The 1,771 commenters urging the U.S. Food and Drug Administration (FDA) to reject its idea include consumers, doctors and other health professionals, academics, individuals in the pharmaceutical industry and various organizations. The FDA’s proposed guidance would undermine the purpose of the agency and put patients at risk, Public Citizen said today in a letter to Secretary of Health and Human Services Sylvia Mathews Burwell.

The draft guidance, issued in June 2014, would give companies that believe that the FDA-approved labeling information overstates risks free rein to tell doctors that the risks are lower. Company salespeople could inform physicians of the purportedly lower risks by distributing peer-reviewed articles – without the agency seeing the articles, reviewing the data or approving them – and discuss with doctors the information about the “lower” risks.

“As most of the comments stated, this proposed guidance is reckless and seriously undermines FDA authority,” said Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group. “The FDA is supposed to be the government shield that protects patients when the industry pushes products that might not have a favorable benefit-to-risk ratio in order to line their own pockets. This guidance completely undermines that safety shield.”

After the agency closed the comment period in August, only one of the 1,782 comments submitted on the proposal was posted on the FDA’s website. On Oct. 15, Public Citizen requested under the Freedom of Information Act the full text of all the comments. After obtaining the comments, Public Citizen read each response, finding only 11 commenters – less than one percent – in support of the proposed FDA guidance. The 11 comments came from pharmaceutical companies and their trade associations, along with a single academic.

“As predicted, the proposal’s few supporters primarily are industry companies and their associations, all of which would benefit from being allowed and encouraged to sell more of their products by making them seem safer than the FDA has judged them to be,” said Wolfe.

After analyzing the comments opposing the guidance, two themes emerged. First, responders viewed it as giving Big Pharma the green light to push information on to patients’ own doctors that contradicts government-approved warning labels. A second related theme was a widespread and increasing distrust of the FDA for proposing such guidance.

Pharma Guy's insight:


ONLY 1 of 1782 comments submitted on the proposal was post dot FDA's website! Incredible! What every happened to FDA's Transparency Initiative?

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4ErickaDavis's curator insight, March 12, 2015 10:12 AM

The bureaucracy being discussed is the FDA. I did not realize that the FDA was in charge of free labeling and how that negatively affected consumers. I agree that this puts people at risk and should be handled. 

Ashley Maddox's comment, March 12, 2015 3:06 PM
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Public Citizen Accuses FDA of a Coverup Re Off-Label Reprints Distribution Guidance

Public Citizen Accuses FDA of a Coverup Re Off-Label Reprints Distribution Guidance | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Public Citizen has told HHS secretary Sylvia Burwell that FDA should withdraw its recent draft guidance on Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products — Recommended Practices because it would allow pharmaceutical companies to tell physicians that marketed drugs could be less risky than FDA-approved labels say they are.


In an October 22 letter to Burwell, the group's founder and senior advisor, Sidney M. Wolfe wrote that  the guidance would allow pharmaceutical salespeople to “inform physicians of the purportedly lower risks by distributing peer-reviewed articles assessing a drug's risks and discussing with doctors the information about the ‘lower' risks, without the FDA reviewing the articles, analyzing the data, or approving distribution of that information.”


His letter also complained about FDA's decision to withhold over 1,700 public comments on the draft guidance, suggesting that it is trying to cover-up criticism of the proposal.


“Of the 1,781 comments submitted on the proposal, only one comment has been posted on the government agency's Web site in the 58 days since the comment period closed,” Wolfe wrote, adding that on 10/15 it requested under the Freedom of Information Act the release of the comments.


Pharma Guy's insight:


Sidney Wolfe Cries Foul!

In a JAMA Internal Medicine viewpoint article pub- lished on August 15, 2014, Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Re- search Group, argues that the draft guidance “suggests that the agency has now tilted toward protecting industry's commercial speech and away from protecting patients from the risks of prescription drugs and biological products” and would “let the pharmaceutical industry essentially circumvent drug labeling rules and tell doctors that its products have fewer risks than those described in the FDA-approv- ed labeling.”

Does Wolfe have a case? 


For more about that, read More FDA Guidance on Distribution of Reprints

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Drug Industry Document Archive - Off-Label Marketing of Zyprexa

Drug Industry Document Archive - Off-Label Marketing of Zyprexa | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The documents in this collection are a portion of those produced in a class action court case that alleged Eli Lilly withheld data on adverse effects such as weight gain and diabetes and participated in off-label marketing of the drug. The documents were first obtained and made public in 2006 by PsychRights.org, expert consultant Dr. David Egilman, attorney Jim Gottstein, and journalists Philip Dawdy and Alex Berenson. After a legal battle over public access, the documents were un-sealed and allowed to remain in the public domain.  These documents highlight Lilly's marketing strategy of influencing key opinion leaders and its attempts to control the research, the scientific literature and regulatory product labeling to minimize information on adverse effects.

Pharma Guy's insight:


This database of documents is interesting, especially in light of FDA's new draft guidance on the distribution of off-label reprints. For more on that, read 

FDA Issues More Guidance Regarding Distribution of Reprints. Is It "Fair and Balanced?"
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FDA's Social Media Guidances Provide Little That's New, Says Coalition for Healthcare Communication

Indeed, at the Drug Information Association Annual Meeting held last week in San Diego, Abrams noted that he expected minimal use of space-limited media because of the agency’s requirements on risk information. Cooke wrote that OPDP’s call for risk information that includes the most serious risks associated with the product, as well as all boxed warnings, makes it “difficult to imagine a product that has fatal or life-threatening risk, contraindications or boxed warnings that could be contained within the space-limited context of a Tweet, which has a 140-character limitation.” For example, he cited one product’s boxed warning, which alone contains 692 characters.


This approach “would limit the availability of space-limited communications to the small subset of prescription products whose risk and benefit information” meet the agency’s requirements, Cooke said, adding that the framework set forth by the draft guidance “seems more amenable to the participation of products with limited risks and short benefit statements.” He told the Coalition that the agency “could have suggested some approved abbreviations to help companies meet the requirements in a limited space – such as using ‘risks incl death’ instead of ‘risks include’ and listing all possible inclusions –but it chose not to.”


In an e-mail to Bloomberg BNA June 17, James N. Czaban, chairman of the FDA Practice Group at Wiley Rein LLP, said that the risk/benefit guidance “is actually very limited in scope” because it does not address many other types of online activity. He also told BNA that “The idea that FDA would allow a black box warning to be condensed for use in the format of Google Sitelinks or even Twitter is quite surprising given existing promotional limitations on black box products, and the length and seriousness of such warnings for many drugs,” Czaban told BNA. “Will any company risk such an approach from a liability perspective, even if it could meet the space limitations?”


Czaban said that “the bottom line is that FDA’s guidance leaves many questions unanswered, and its examples are of limited utility.”

Pharma Guy's insight:


Here's how I believe pharma can create a compliant tweet INCLUDES a 692-character boxed warning: A Type of Rx Drug Tweet FDA Did Not Consider in its Recent Guidance

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FDA Guidance Says Companies Have Broad Leeway to Correct Misinformation

FDA Guidance Says Companies Have Broad Leeway to Correct Misinformation | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The US Food and Drug Administration (FDA) has released a new draft guidance document on social media focused on how companies can correct blatant misinformation contained on the Internet and social media channels, long a source of frustration for FDA-regulated companies.


The agency is now out with its third social media draft guidance, Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.


As FDA explains in the guidance, the Internet has made is considerably easier for outside third parties—from other companies to consumers—to disseminate information about drugs, including factually incorrect or misleading information.


And that information sometimes finds its way onto websites where the sponsor of a drug product has the opportunity to correct misinformation about the product. The question companies have had until now is, ”How can we do so without falling afoul of FDA regulations on product promotion?”


The fear of some companies was that by responding with anything other than full and complete prescribing information, the companies might be cited for misleading promotion. And in many forums, companies are constrained in the space they have to respond to someone.


The good news for companies: FDA says it "does not intend to object" if a company "voluntarily corrects misinformation [posted by a third party unaffiliated with the company] in a truthful and non-misleading manner"—a manner described in FDA's latest draft guidance.

Pharma Guy's insight:


In Example 11 of the guidance document, FDA says:


“A firm finds a webpage about its product that was written by an independent third party on an Internet-based, interactive, collaboratively edited encyclopedia. The firm may choose to contact the author of the webpage and provide corrective information to the author.”

 

Obviously, FDA is referring to Wikipedia when it talks about “an independent third party on an Internet-based, interactive, collaboratively edited encyclopedia.” Although pharma companies may be able to contact the author of “misinformation” by leaving a message on the author’s talk page, that message may be ignored.

 

There’s a better way, which I wrote about in Pharma Marketing News.

 

In that article (find it here http://bit.ly/pmn130302p ), I wrote about the “right way” to correct Wikipedia articles:

 

Recall that back in June, 2012, Dr. Bertalan Meskó (@Berci), in an open letter to pharma, urged the pharmaceutical industry to employ Wikipedia editors and thus "funnel [their] vast resources" to help.

 

"Based on the pretty negative past encounters between pharma employees and Wikipedia editors (pharma employees trying to edit entries about their own products in a quite non-neutral way), we advise you to employ a Wikipedia editor if you want to make sure only evidence-based information is included in entries about your own products,” said Berci in 2012 (see http://bit.ly/pmn11602).

 

“Appointing someone from within your company as a 'spokesperson' in Wikipedia who would perform all edits on behalf of the company is an excellent way to update those entries," said Berci.

 

You would think that the pharmaceutical industry would have jumped at the chance to establish a liaison with Wikipedia to help edit articles about their products. At least one pharma company, in fact, did seem to endorse the idea, at least in principle.

 

Boehringer Ingelheim (BI) responded to Berci via Twitter: "We look for patient safety issues & react. Its important to stick to Wikipedia policies too, so all transparent." But when asked by Berci if BI had posted anything online about this, BI responded "No at this point in time we have not....yet." He remains optimistic.

 

In a PMN survey, 57% of respondents agreed that pharma companies should appoint an official Wikipedia editor (see chart above and survey summary here: http://bit.ly/pgdaily012914-2A). 

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Joel Finkle's curator insight, June 19, 2014 1:03 PM

More on FDA and social media use

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FDA's Reprint Distribution Guidelines are "Counterintuitive" & "Indecent"

FDA's Reprint Distribution Guidelines are "Counterintuitive" & "Indecent" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The consumer watchdog group Public Citizen garnered significant attention this week when it raised an alarm against an FDA proposal that would enable pharmaceutical companies to distribute new drug safety data from clinical trials directly to doctors, prior to FDA review for a potential label change. Its concern is that this proposal would allow pharmaceutical companies to publicize medications as "more safe" than what the FDA approval process had previously revealed.


As noted in a Reuters article covering Public Citizen's protest, "Last June the Food and Drug Administration proposed allowing the distribution of new risk information about approved drugs, saying that a drug's safety profile "evolves" as exposure to the product increases." And yet the article states, "Companies would not be allowed to distribute literature about newly identified risks or information that shows an already identified risk is more serious than stated on the label. Such information would need to be reviewed by the FDA and potentially included in the label."


Huh? Why would FDA acknowledge that as new information emerges it changes the safety profile of a drug (which it does -- see Table 1), but that those data should only be conveyed if drugs are presenting as more safe than expected? Isn't that totally counter-intuitive. More safe is like an added bonus, a surprise treat in the cereal box. Less safe? As in new, unanticipated side effects, isn't that what people really need to know about? And quickly? Isn't the FDA's primary goal to ensure the safety of the public at large? How could keeping dangerous side effects a secret be a good thing for anyone?



Pharma Guy's insight:


I believe the FDA is tipping the balance in favor of commercial "free speech' and away from drug safety. For more on that read and a review of the FDA guidelines, read this Pharma Marketing News Article:  "More FDA Guidance on Distribution of Reprints." 


Topics include (partial list):

  • Some Off-Label Litigation History
  • A String of Off-Label Guidances
  • WLF vs FDA
  • Criteria of Approved Off-Label Studies
  • Sidney Wolfe Cries Foul!


Download the full text PDF file here:
www.pharma-mkting.com/news/pmnews1308-article02.pdf

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FDA Prohibits Package Inserts in DTC Print Ads & Recommends New "Consumer Brief Summary"

FDA Prohibits Package Inserts in DTC Print Ads & Recommends New "Consumer Brief Summary" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

On February 4, 2004, the FDA issued long-awaited draft guidance documents designed to improve communications to consumers and health care practitioners about health conditions and medical products. One document was titled “Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements.”

“Our new regulatory guidance,” said Mark B. McClellan, M.D., Ph.D., FDA Commissioner at the time, “provides new direction to sponsors on how to provide higher-quality health information to the public, based on recent evidence on what works and what doesn't in drug promotion” (read "FDA Draft Guidance for Print DTCA: Less than Feared").

But now even NEWER evidence - and complaints from the pharma industry - forced the FDA to issue a "revised draft guidance" titled "Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs," which you can find here (Docket No. FDA-2004-D-0500).

Released on February 9, 2015, this revision was ELEVEN years in the making. Compared to that, the four years FDA took to issue draft social media guidelines was lightening fast.

The guidelines address the requirement under provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which require that an advertisement for a prescription drug to disclose each side effect, warning, precaution, and contraindication from the labeling. This is referred to as the "brief summary requirement."

So what's new in the guidelines? Read more...

Pharma Guy's insight:


One consumer-friendly format that FDA recommended is a "Prescription Drug Facts Box," which is based on a format used for OTC products. In 2009, a Dartmouth Study concluded that a "Fact Box" on risk/benefit is good for consumers. The study included a mock up of a Fact Box for Lunesta (shown below), a popular sleep aid drug that was heavily advertised to consumers at that time.

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FDA's "Off-Label Risk Reduction" Approach to Reprint Distribution is "Misguided," Says Sidney Wolfe

FDA's "Off-Label Risk Reduction" Approach to Reprint Distribution is "Misguided," Says Sidney Wolfe | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In June, the FDA issued a THIRD draft guidance document regarding reprint distribution by pharmaceutic companies. This new guidance describes FDA’s recommendations for distributing reprints that convey "new risk information" for approved drugs.


In a JAMA Internal Medicine viewpoint article published today, Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, argues that the draft guidance "suggests that the agency has now tilted toward protecting industry's commercial speech and away from protecting patients from the risks of prescription drugs and biological products" and would "let the pharmaceutical industry essentially circumvent drug labeling rules and tell doctors that its products have fewer risks than those described in the FDA-approved labeling."

Does Wolfe have a case?

Pharma Guy's insight:


Take my little poll at the end of this post:


Do you agree that new risk information should only be conveyed in the drug's labeling, not via reprints?

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Did FDA Avoid the "Social Media Guidance Cliff"?

Did FDA Avoid the "Social Media Guidance Cliff"? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Section 1121 of the Prescription Drug User Fee Act (PDUFA) states: "Not later than 2 years after the date of enactment [signed into law on 9-July-2012], FDA shall issue guidance describing FDA policy regarding Internet promotion, including social media, of medical products regulated by FDA" (see here). 

I call this the "Social Media Guidance Cliff."

Pharma Guy's insight:


Well, today is exactly two years after PDUFA V was signed into law. While FDA has issued a few social media guidance documents, it still has one more to go: Use of Links


FDA's "Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2014," which was published in January 2014, promised that it would publish that guidance sometime in 2014 (see here).


Section 1121 was not specific as to how many social media guidances FDA should issue before toddy's deadline. So I guess FDA is off the hook as far as complying with section 1121 is concerned.

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Tweet #Risks as Well as #Benefits, #FDA Tells #Pharma

Tweet #Risks as Well as #Benefits, #FDA Tells #Pharma | Pharmaguy's Insights Into Drug Industry News | Scoop.it
“Don’t use Viagra if your heart isn’t healthy enough for sex.” After that warning, Pfizer Inc. will have just 81 letters left to tweet about the benefits of its erectile dysfunction drug, say U.S. regulators.


Drug and device makers who send social media messages on services like Twitter will be required to include the risks and benefits of their products when they do so, the Food and Drug Administration proposed today in two draft guidelines. That means packing that information inside the strict 140-character limit of the social media site from Twitter Inc. (TWTR)


Drugmakers have been awaiting the guidelines since the FDA held a publicmeeting in 2009 to gather input on social media promotion. Companies have avoided tweeting about products as they wait on the FDA, Lori Leskin, a partner at the law firm Kaye Scholer LLP in New York, said in an interview.


“I think this is clear enough guidance you’ll start seeing more tweets,” Leskin said. “It’s the more significant drugs that do have black box warnings, that do have more significant risk, that are used in limited populations that this won’t be appropriate for.”

Pharma Guy's insight:


We'll start seeing tweets... Really? I don't think so! Lawyers... what do they know? Read my take on this: 

FDA to Pharma: Forget About Tweets! But You Can Host Discussion Forums About Branded Rx Products, Sorta, & Kinda Correct Misinformation

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FDA Finally Proposes Social Media Guidelines

FDA Finally Proposes Social Media Guidelines | Pharmaguy's Insights Into Drug Industry News | Scoop.it
After several years of anticipation, the FDA has finally proposed a pair of guidelines for how drug and device makers should cope with some of the challenges and pitfalls posed by social media.


One of the so-called draft guidances offers instructions on how companies should attempt to correct product information on websites that are run by others, such as chat rooms. The otheraddresses how products – including risk and benefit information – can be discussed in venues such as Twitter, as well as paid search links on Google and Yahoo, all of which have limited space. This will involve using links to product web sites, for instances, that can be clicked.


“These are intended to have a beneficial impact on public health,” Tom Abrams, who heads the FDA Office of Prescription Drug Promotion, tells us. “But these were not developed in a vacuum. They were developed with careful consideration and with input from industry and many other stakeholders. There was a lot of important consideration given to the issues.”


For third-party websites, suchas Wikipedia, the draft guidance suggests that companies should feel free to correct misinformation, but that any correction must include balanced information and the source of the revision or update must be noted, Abrams explains. This means a company or company employee or contractor should be credited with any additions.


“The information should not be promotional and should be factually correct. This is not an opportunity for a company to tout its drugs,” he says. “The information [being added or revised] should be consistent with the FDA-approved [product] labeling and for it to be effective, you want it posted right by the misinformation.”


The guidance also says that companies should contact writers, such as bloggers, to make changes when they learn of misinformation. Abrams notes companies will not be held responsible for those who do not make changes. If none of this is possible, he says companies should contact web site operators and suggest they delete the misinformation or open the site to comments so that corrections can be made.

Pharma Guy's insight:


Well, well, well. I can't believe it! And I thought FDA would miss the July 2014 deadline imposed by Congress. For more on that, read: Will FDA Avoid the "Social Media Guidance Cliff"?

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