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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Public Citizen's Challenge to Trump’s ‘One-In, Two-Out’ Executive Order on Regulations

Public Citizen's Challenge to Trump’s ‘One-In, Two-Out’ Executive Order on Regulations | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Public Citizen, the Natural Resources Defense Council (NRDC) and the Communications Workers of America sued the Trump administration today to block an executive order signed by President Donald Trump on Jan. 30 that directs federal agencies to repeal two federal regulations for every new rule they issue.

The plaintiffs are asking the court to issue a declaration that the order cannot be lawfully implemented and bar the agencies from implementing the order.

The order requires new rules to have a net cost of $0 this fiscal year, without taking into account the value of the benefits of public protections.

The suit, filed in the U.S. District Court for the District of Columbia, names as defendants the president, the acting director of the Office of Management and Budget (OMB) and the current or acting secretaries and directors of more than a dozen executive departments and agencies. The complaint alleges that the agencies cannot lawfully comply with the president’s order because doing so would violate the statutes under which the agencies operate and the Administrative Procedure Act.

"No one thinking sensibly about how to set rules for health, safety, the environment and the economy would ever adopt the Trump Executive Order approach – unless their only goal was to confer enormous benefits on big business,” Public Citizen President Robert Weissman said. “If implemented, the order would result in lasting damage to our government’s ability to save lives, protect our environment, police Wall Street, keep consumers safe and fight discrimination. By irrationally directing agencies to consider costs but not benefits of new rules, it would fundamentally change our government’s role from one of protecting the public to protecting corporate profits.”

Pharma Guy's insight:

Further Reading: “FDA Regulation Cutting Will Impact Drug Approvals Too”; http://sco.lt/6XmjR3

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Have Hefty DOJ Fines Made Pharma Marketers More Compliant with FDA Regulations?

Have Hefty DOJ Fines Made Pharma Marketers More Compliant with FDA Regulations? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Is the number of warning letters low because pharmaceutical marketers have learned to be more compliant with FDA regulations or is there some other reason?


Could it be that pharma marketers have become more compliant with FDA regulations because their MLR people became more assertive after many major pharma companies, which do a lot of drug marketing, were fined billions of dollars for inappropriately, and in some cases illegally, promoting prescription drugs?

Pharma Guy's insight:


DOJ fines are much more persuasive than "slap on the wrist" notice of violation letters from the FDA. As they say, "money talks, nobody walks." 

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Pharma Guy's curator insight, March 31, 2016 6:25 AM

 

DOJ fines are much more persuasive than "slap on the wrist" notice of violation letters from the FDA. As they say, "money talks, nobody walks." 

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Has Gilead's Director of Regulatory Affairs Been Hiding Under a Rock Since 2009? Will He Be Fired or Praised?

Has Gilead's Director of Regulatory Affairs Been Hiding Under a Rock Since 2009? Will He Be Fired or Praised? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

At the end of June, the FDA sent a Notice of Violation (NOV) letter to Naumann Chaudry, Director, Regulatory Affairs Advertising and Promotion at Gilead Sciences, citing a sponsored link on Google for VIREAD (you can find the letter here).


Unless Dr. Chaudry (he has a PharmD degree) has been hiding under a "regulatory rock" since 2009, it's difficult to imagine that he would have approved such an ad. Because as WE all know, FDA views such ads, which include the drug brand name AND indication but no fair balance safety information, as violative of the FD&C Act.

Anyone, such as Dr. Chaudry, who is a regulatory authority -- he's worked in a regulatory capacity for several pharma companies since 2004 -- should be aware of FDA's "received precedent" on this type of ad (i.e, 14 warning letters issued in April 2009).

VIREAD is associated with serious risks and includes a black box warning. To advertise such a drug without providing any mention of such risk is unconscionable.

But there are even more serious problems with this ad, that, IMHO, should get Dr. Chaudry in hot water with Gilead's CEO and perhaps fired!

Pharma Guy's insight:


What do you think? Should Dr. Chaudry be fired?

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Patient Testimonials aka Anecdotal Experience #Pharma Marketing

Patient Testimonials aka Anecdotal Experience #Pharma Marketing | Pharmaguy's Insights Into Drug Industry News | Scoop.it

People like to get information from people they trust. Moreover, a hallmark of digital communications has been a turning away from large, institutionalized sources for information and turning instead to hear from individuals.

There appears to be good reason for the use of testimonials by patients when seeking to promote a medical product. A patient like me who has faced what I faced and now has been through the experience tells me what it is like, and I may take great stock in what they say.

But while it may make sense, there may be inherent regulatory risks in going down that path – risks that are peculiar to use of testimonials. Why?

Part of the appeal in having a patient describe their experience using a medical product is that they provide a real, first-person description of how the product worked for them and the difference it made for them with respect to their condition. That is also the drawback.

I was able to identify 12 instances in which FDA sent a letter regarding a communication that involved a patient testimonial – in 3 of those instances the patient was also a celebrity spokesperson.

When it comes specifically to patient testimonials, the most common violation was the overstatement of efficacy, involving 11 of the 12 letters.

The basis for that is likely that when a person describes in subjective terms their experience with a medication, it usually includes a reference to the impact the use had on their lives. Phrases such as it “literally changed my life” and “restored my confidence” or describing in personal terms the use of the medication for which evidence does not exist to demonstrate that everyone would have such an experience.

Almost all of the communications vehicles involved video, but it also involved some print.

Pharma Guy's insight:

Pharma marketers are capitalizing on the e-Patient movement by leveraging social media, online video, and real patient stories in an effort to become more "patient centric" (see, for example, "Patient Story-telling Marketing"). Add a celebrity spokesperson who is also a patient or a caretaker of a patient and you've got gold!

But in some cases, this practice may be going too far. Can anecdotal "evidence"/experiences mentioned in patient videos -- even unbranded videos -- cause unnecessary visits to the doctor's office and over prescribing of drugs with serious side effects? For more on that, read "Are Patient Stories Becoming Anecdotal 'Evidence' in Pharma Marketing Campaigns?"; http://bit.ly/patstorymkting 

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Pharma Guy's curator insight, March 28, 2016 8:09 AM

Pharma marketers are capitalizing on the e-Patient movement by leveraging social media, online video, and real patient stories in an effort to become more "patient centric" (see, for example, "Patient Story-telling Marketing"). Add a celebrity spokesperson who is also a patient or a caretaker of a patient and you've got gold!

But in some cases, this practice may be going too far. Can anecdotal "evidence"/experiences mentioned in patient videos -- even unbranded videos -- cause unnecessary visits to the doctor's office and over prescribing of drugs with serious side effects? For more on that, read "Are Patient Stories Becoming Anecdotal 'Evidence' in Pharma Marketing Campaigns?"; http://bit.ly/patstorymkting 

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Is the FDA Sexist? Regulators Pressed to OK Drugs for Female Sex Problems

Is the FDA Sexist? Regulators Pressed to OK Drugs for Female Sex Problems | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Is the FDA guilty of gender bias? A coalition of consumer advocacy groups and drug makers recently launched an online campaign – complete with a petition – to pressure the FDA to approve more drugs to treat female sexual dysfunction. Called Even The Score, the crusade claims that there are more than two dozen drugs available to help men combat sexual problems, but none for women.


A key backer is Sprout Pharmaceuticals, a privately held drug maker that has been haggling with the FDA over approval of its flibanserin treatment. The drug was once owned by Boehringer Ingelheim, but later sold to Sprout after an FDA rejection. Last fall, the agency rejected the pill again and Sprout responded in December by taking the rare step of filing an appeal, even though such efforts often go nowhere.

Pharma Guy's insight:


Boehringer gave up on flibanserin -- so-called "Female Viagra" -- after the FDA refused to approve it for female sexual arousal disorder, also known as hypoactive sexual desire disorder (HSDD), which is a relatively new diagnosis.

Recall that I blasted the trial data Boehringer submitted to the FDA before the FDA decision (see here). The data from that trial showed that women taking flibanserin experienced 0.8 more "satisfying sex acts" per month than did women taking a placebo. By the way, a "satisfying sex act" can include ... wait for it ... masturbation!


Now, Sprout Pharmaceuticals is trying to get this drug approved. Sprout claims that a NEW trial of 1,000 patients (Study 511.147) published in the Journal of Sexual Medicine, resulted in "statistically significant improvements in the number of satisfying sexual events (SSEs), as well as increase in sexual desire when compared with placebo."

I don't have access to the data, but the description (here) of endpoints sounds very suspicious of data manipulation.


Read more about that here: Lack Sexual Desire? Try, Try Again!

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