PHARMA NEWS, MULTICHANNEL & CROSSCHANNEL MAKETING

The FDA just broke a recent record for most new drug approvals in a year, hitting a not-entirely meaningful (but not altogether meaningless) milestone for an agency that has long promised to pick up the pace.

With today’s green light of La Jolla Pharmaceutical Company’s Giapreza, a treatment for dangerously low blood pressure, the FDA hit 46 approvals for the year. That’s the most in at least a decade.

We’re looking at only approvals from the FDA’s drugs division, which considers pills and injections that treat disease. So-called living products, including vaccines and gene therapies, are approved by a different division at the agency and counted separately.

Further Reading:

• “Big Pharma Had a Bumper Crop of New Drugs Approved in 2017, But Profitability Shrinks”; http://sco.lt/7OtdVx

Welcome to the October 31, 2017, issue of Pharma Industry News Update (aka PinUp). 

Some experts are 'heartbroken' that the pharmaceutical industry has not done more in the digital health arena and they blame it on belief in "myths" about FDA regulations. Good luck busting those myths! Another myth is that education programs promulgating the old "just say no to drugs" campaign are going to help end the current opioid epidemic. The last myth that deserves mentioning is that the drug industry is not culpable.

**********ARTICLES***********
 * Five Regulatory Myths About FDA Regulation of Pharma in the Digital Health Arena
* Trump Has Not Grasped What’s Needed to Combat Opioid Crisis
* Dancing with Fentanyl: Insys Sales Reps Caught Rapping to Boost Sales

Access this issue here.

About Pharma Industry News Update

The Pharma Industry News Update (aka PinUp) is published every Tuesday and Friday as part of the Pharma Marketing News subscription service. It features curated pharma industry news and views of topical interest from a variety of sources. If you'd like to receive this newsletter, subscribe here.

About the Author

John (PharmaGuy) Mack is a constructive critic of the pharmaceutical industry. You can follow him on Twitter as @pharmaguy

Digital tools offer an opportunity to revolutionize bio/pharma care, so why isn’t more being done faster?

Bio/pharma is desperate to offer new value to patients, providers and payers, and digital can unlock both clinical and economic outcomes.

That’s why we are heartbroken when these companies barely dip their toe in the digital waters. They want to move faster, but fear of regulatory consequences is creating significant friction and even paralysis.

No doubt there are valid issues to manage and unknowns to navigate. At the same time, at least some regulatory fears are rooted in myths rather than facts. By busting these myths, bio/pharma can more confidently enter the digital health market.

TOP 5 MYTHS

1. FDA wants to tightly regulate bio/pharma software.
2. Companion digital health developers always create regulatory risk for bio/pharma.
3. Any clinical trial software will be regulated as a medical device.
4. Any bio/pharma software must be approved via a supplemental NDA.
5. Bio/pharma companies must report adverse events in any databases they touch.

The FDA, in an effort to bring promising new therapies to patients as quickly as possible, has introduced a spate of shortcuts to speed up the approval process. Those programs are working as intended, new research finds, but drug companies are often loath to fulfill their obligations.

The big idea behind the FDA’s accelerated drug approval program is that regulators will OK a promising drug based on clues that it will improve patient lives, so long as pharma companies later carry out larger trials to confirm those hints of efficacy. But looking at four years of data, a team of researchers found that only 50 percent of those trials actually took place within three years of approval.

Furthermore, 44 percent of such trials were not the placebo-controlled variety considered to be the gold standard but rather relied on the same surrogate measures used to win a quick approval, leaving each drug’s true value unclear. This was particularly striking for cancer drugs, accounting for 80 percent of studied approvals, which were cleared based on how well they shrank tumors, not how long they kept patients alive.

Further Reading:

• “GAO Report: FDA Expedites Drug Approvals, But Its Postapproval Oversight Stinks!”; http://sco.lt/89j3Zp
• "FDA is Lax in Enforcing Law Regarding Prescription Drug Postmarketing Studies"; http://bit.ly/1PoqAsY

The number of new drugs approved for sale in United States and Europe has bounced back this year [so far], suggesting a marked slowdown in 2016 was an aberration rather than a sign of flagging research and development productivity.

The U.S. Food and Drug Administration has already cleared 21 new prescription medicines for sale against 22 in the whole of 2016 (read “New Drugs Approved by FDA in 2016 is Half the Number Approved in 2015”; http://sco.lt/55JaUb), and just nine at this stage last year.

The European Medicines Agency has recommended 42 compared with a 2016 total of 81, and 31 in the first five months of last year. Unlike the FDA, the EMA includes generic or non-patented drugs in its list.

John LaMattina, a former research head for Pfizer and a board member at PureTech Health, is unsurprised by the rebound and believes concerns raised at the end of 2016 about deteriorating drug pipelines were "far too dire".

Hilary Thomas, chief medical adviser at KPMG, said U.S. regulators in particular were showing an innovative approach that was helping to accelerate approvals - as highlighted by a novel decision to clear a cancer drug for the first time based on genetics, not tumor location.

Still, the targeted nature of many new medicines will limit the overall patient population getting the latest wave of novel drugs.

"What the data masks is that while there might be more approvals, the total number of people getting new drugs is probably not going to up hugely because these are more specific, personalized treatments," she said.

Welcome to the February 28, 2017, edition of Pharma Industry News Update (aka PinUp), which is published every Tuesday and Friday as part of the Pharma Marketing News subscription service. PinUp presents selected content of topical interest from a variety of sources. View the Web version of this issue here: http://bit.ly/PINUP022817  

Articles in this issue:

• “2016: A Record-setting Year for Generic Drug Approvals by FDA”; http://sco.lt/59bhlx
• “The Top 10 U.S. Drug Patent Losses for 2017”; http://sco.lt/59bhlx
• “Will You Miss Those ED DTC TV Ads When Viagra & Cialis Go Generic?”; http://sco.lt/5bsTdh

Further Reading:

• Over 700 Generics Were Approved by FDA in 2015: http://sco.lt/5cKsan
• FDA Approves First Generic Version of Crestor: http://sco.lt/7YcXYH
• Senators to FDA: "Please Explain" Why the Hell You Stymied EpiPen Competition!: http://sco.lt/6RgsUb
• "Lockstep" Price Increases by #Pharma Competitors Keep Rx & Generic Drug Costs High: http://sco.lt/6mWNsn
• Off-patent Drugs at Brand-Name Prices: A Puzzle for Policymakers: http://sco.lt/6zHDk1

About Pharma Industry News Update

The Pharma Industry News Update (aka PinUp) is published every Tuesday and Friday as part of the Pharma Marketing News subscription service. It features curated pharma industry news and views of topical interest from a variety of sources. If you'd like to receive this newsletter, subscribe here.

The US Food and Drug Administration (FDA) is planning to study whether links can be sufficient means of presenting risk information about drugs in advertising on social media platforms, such as Twitter, where character space is limited.

"The objective of this research is to test whether a link to prescription drug risk information can effectively convey the risks associated with a drug when benefit claims about the drug are made within character-space-limited communications used in prescription drug promotion," FDA says (here).

To test this theory, FDA says it plans to conduct four studies, two involving Twitter and two using Google sponsored links, to determine how well participants understand and retain risk information depending on whether the information is contained within the communication or merely linked to.

Under current regulations for prescription drug promotion, drugmakers are required to include a balance of information regarding a drug's benefits and risks. However, on many social media platforms the amount of space for text is limited. For instance, Twitter allows just 140 characters per "tweet," making it difficult or impossible for drugmakers to promote their products on the platform.

"The rise of Internet communications that have character space limitations, such as sponsored link promotion and microblog messaging, has led to questions about how to use these communications for prescription drug promotion while complying with the fair balance requirements," FDA says.

While FDA has yet to provide final guidance on pharmaceutical advertising on character-space-limited platforms, the agency's approach in its draft guidance would require risk information in the body of a communication.

"Regardless of character space constraints that may be present on certain Internet/social media platforms, if a firm chooses to make a product benefit claim, the firm should also incorporate risk information within the same character-space-limited communications. The firm should also provide a mechanism to allow direct access to a more complete discussion of the risks associated with its product," the draft guidance states.

However, many in industry have argued that risk information can be presented effectively by including a link to a page that discusses the benefits and risks of a product more fully, and that including risk information in the communication itself is unnecessary (for more on that, read: "Overcoming Space Limitations in Social Media"; http://sco.lt/9LmYmv).

AbbVie, Astrazeneca, Eli Lilly, GSK, Merck, Regeneron Pharmaceuticals, plus others have submitted comments to the FDA regarding its plans to research animated spokes-characters in DTC Drug Ads (see Federal Register Docket ID: FDA-2016-N-0538).

Merck was not impressed: “While the proposed collection of information may be interesting to learn, it may not have practical utility for the general public and may be unnecessary for the proper performance of FDA's functions.”

Regeneron expressed a similar concern; i.e., "the results from this study should not be used to guide or influence FDA's current thinking on the use of animation in DTC ads."

But FDA is sticking to its guns.

“On the contrary,” says FDA in response, “this particular study has the potential to directly influence policy in an area that we have no prior research on. Although one research study cannot answer all questions, we believe we have designed the study in such a way that we will be able to provide information on the issue of animation in DTC ads. Because there is no previous research of this kind, this will be an informative study that will help FDA develop guidance and policy in the future, should the research reveal a need to.”

Meanwhile, The Advertising Coalition, representing national trade associations whose members prepare and deliver advertising through television, newspapers, magazines, the Internet, whipped out its 1st Amendment gun: “[T]his study must be viewed through the lens of two Supreme Court rulings that explicitly protect Commercial Speech, including advertising. In particular, the FDA must be mindful of the Supreme Court's ruling in Zauderer v. Office of Disciplinary Counsel, which held a state regulation of an advertising illustration unconstitutional and subject to strict scrutiny.”

But the comments I found most interesting had to do with the "Uncanny Valley” Hypothesis and measuring the “eeriness” of certain animated ads. More...

The FDA has entered into the federal register a new draft guidance  pertaining to "software as a medical device" (SaMD). The guidance is presented as representing the FDA's current thinking on establishing clinical evaluation guidelines for SaMD, but is written by an international organization of device regulators, the International Medical Device Regulators Forum, of which FDA is a member.

The guidance seeks to articulate what's new and different about SaMD (a category which would include mobile medical apps) and provide a stratified guidance on how to regulate different kinds of software and what kind of evidence is needed for each regulatory category. The guidance stratifies devices on two axes: whether the device informs care, drives care, or treats/diagnoses and whether the condition in question is non-serious, serious, or critical. So software that treats or diagnoses a critical condition is in the highest risk category, while software that informs care about a non-serious condition is in the lowest.

The guidelines also call out and address the fact that software development tends to move faster than traditional medical device development and can more easily be influenced by postmarket data.

"SaMD ... is unique in that it operates in a complex highly connected-interactive socio-technical environment in which frequent changes and modifications can be implemented more quickly and efficiently," the guidance says. "Development of SaMD is also heavily influenced by new entrants unfamiliar with medical device regulations and terminology developing a broad spectrum of applications."

FDA’s Center for Drug Evaluation and Research (CDER) is sponsoring a daylong public workshop on March 31, 2016, titled Navigating CDER: What You Should Know for Effective Engagement. Our presentations will help patient advocates gain a better understanding of FDA and provide specific resources to help you and your colleagues learn ways to effectively advocate and engage with the Agency on behalf of the patients you serve.

We’ll provide a broad overview of patient engagement with various offices within CDER, and drill down into key specifics such as:

• Who and when to call;
• How to set up a meeting at FDA;
• Provide tips on making the most out of your meeting; and,
• How to prepare an effective presentation for FDA staff.

We’ll also discuss topics such as understanding labeling, generic drugs, and how patients can effectively interact and provide input to FDA. And, we’ll look at some programs including different drug approval processes, expanded access, and FDA’s role in patient focused drug development (PFDD).

These are only a few of the many important areas we’ll tackle.

Back in June in a posting about the new (relatively) live streaming capability brought to use by Periscope. The app, acquired by Twitter prior to its launch early in 2015, allows you to live stream content from where you are to your followers who can provide commentary – and to allow your Twitter followers to see it afterwards, including the comments. Periscope, in essence, allows you to be your own reporter. In the June posting, I talked about how it might be used to film AdComm outcomes and that it had great utility in healthcare for developments and announcements at medical meetings. 

But would a pharma company use Periscope? Are there special regulatory concerns that might be in play given this particular digital venue? Here are thoughts on each question.

So are pharma companies using Periscope?  You bet. 

I checked out this list of the top 25 pharma companies by global sales.  I found that 10 of them – or 40 percent of the top 25 pharma companies – appeared to have established Periscope feeds and some of them are even following the Eye on FDA Periscope feed (thank you!). They ranged in the size of followership from 0 (though for each of these, I became a follower so now they have at least 1 follower) to 717. I have heard of at least one company holding an event using their Periscope feed.

Which brings us to the second question – are there concerns that regulatory might bring up associated with Periscope use?

What if a company were running a broadcast of a patient group at a medical meeting and someone mentioned an off-label use? What if they stated something that was misinformation about the product? What if they mentioned an adverse event?

"CDRH [FDA's Center for Devices and Radiological Health] does not intend to examine low risk general wellness products to determine whether they are devices within the meaning of the FD&C Act," says a new guidance posted today on the FDA website ("General Wellness: Policy for Low Risk Devices. Draft Guidance for Industry and Food and Drug Administration Staff").

Note: There is no "2." in the algorithm, but I assume it's the last paragraph. In any case, the examples cited by the FDA may better illustrate FDA's thinking. Three out of 4 of these examples involve mobile apps:

Illustrative Example 1: A mobile application plays music to “soothe and relax” an individual and to “manage stress.”

These claims relate only to relaxation or stress management, not to any disease or medical condition, and thus are general wellness claims. In addition, the technology to play music does not present inherent risks to a user’s safety. Therefore, this product meets both criteria for a low risk general wellness product. 

More examples...