Certifying Prescription Grade Smartphone Medical Apps

An article in yesterday's NYT focused on what I call "Prescription Grade Smartphone Medical Apps." The article said the idea of such apps "excites some people in the health care industry, who see them as a starting point for even more sophisticated applications that might otherwise never be built" (read the article here).

"But unlike a 99-cent game, apps dealing directly with medical care cannot be introduced to the public with bugs that will be fixed later. The industry is still grappling with how to ensure quality and safety." I have written about this issue before, although for apps created by the pharma industry and not "Prescription Grade" apps. See, for example:

• Some Unregulated Physician Smartphone Apps May Be Buggy
• FDA Mobile Regulatory Fear Mongering by PhRMA
• Be Aware of What's Behind a Pharma Mobile App: Disclaimers Only Tell Part of the Story

Lee H. Perlman, managing director of Happtique, a subsidiary of the business arm of the Greater New York Hospital Association, says "he believes that doctors will soon prescribe both clinically tested apps and more modest apps, like those that track physical activity or remind patients to take their pills. The company has established its own set of guidelines to determine the quality of health care-related apps, and helps doctors integrate them into their medical practice."

Happtique, in July 2012, released a draft of standards that it will be using to certify medical, health, and fitness apps under Happtique’s App Certification Program. The purpose of the program is to help users identify apps that meet high operability, privacy, and security standards and are based on reliable content. You can find the Happtique certification draft standards attached to this post.

The Happtique Certification Standards include these categories:

• App Operability Standards
• App Privacy Standards
• App Security Standards
• App Content Standards

My interest at the moment is in the App Content (C1) and Security (S6) Standards because these are most relevant to my concerns about the credibility of some recent pharma apps.

Content Standard C1 states: "The app is based on one or more credible information sources such as an accepted protocol, published guidelines, evidence-based practice, peer-reviewed journal, etc.

Performance Requirements for Standard C1

• C1.01 If the app is based on content from a recognized source (e.g., guidelines from a public or private entity), documentation (e.g., link to journal article, medical textbook citation) about the information source is provided.
• C1.02 If the app is based on content other than from a recognized source, documentation about how the content was formulated is provided, including information regarding its relevancy and reliability

I have seen pharma apps that do not comply with C1.01 (e.g., read "Be Aware of What's Behind a Pharma Mobile App: Disclaimers Only Tell Part of the Story").

But more troubling than the lack of documentation regarding content, is the accuracy of the apps software. Happtique Certification Security Standards address some of my concerns.

Security Standard S6 states: "The app owner has a mechanism to notify end users about apps that are banned or recalled by the app owner or any regulatory entity (e.g., FDA, FTC, FCC)."

Performance Requirements for Standard S6

• S6.01 In the event that an app is banned or recalled, a mechanism or process is in place to notify all users about the ban or recall and render the app inoperable.
• S6.02 In the event that the app constitutes a medical device (e.g., 510(k)) or is regulated by the FDA in any other capacity, the app owner has a policy and a mechanism in place to comply with any and all applicable rules and regulations for purposes of handling all aspects of a product notification or recall, including all corrections and removals.

Unfortunately, I do not find a standard for addressing the problem of "buggy" medical app software, which I discussed in a previous post to Pharma Marketing Blog (see "The Problem with Unregulated "Calculator" Apps for Physicians"). Specifically, shouldn't there be some certification standard that specifies how the app software was tested for accuracy? I think so.

Positive or Not, Pediatric Drug Trials Pay Off: Cymbalta and Oxycontin Case Studies

Very few people may know that drug companies can get an additional six months of market exclusivity from FDA as an inducement for them to study the efficacy and safety of drugs in children. Fewer people realize that no matter what the outcome of such tests, FDA will still grant the additional 6 months of exclusivity before generic copies of the tested drug can be introduced.

A case in point is Cymbalta, an antidepressant marketed by Lilly.

As reported in the Wall Street Journal (here), Cymbalta will have an additional six months of U.S. market exclusivity -- through December 2013 -- because the company studied the drug's effects on children. "Lilly said, however, that it won't seek regulatory approval to market Cymbalta for pediatric use because study results were inconclusive regarding Cymbalta's efficacy in children."

Cymbalta is the "duct tape" of drugs; i.e., it has many approved indications for use in adults.

Cymbalta was originally approved in 2004 for adults with major depression. Later the FDA granted Lilly approval to market Cymbalta for treating nerve pain in diabetics, GAD (ie, "generalized anxiety disorder"; see "eGAD! How I Learned to Stop Worrying and Love Cymbalta!") and fibromyalgia, a condition characterized by chronic fatigue and muscle and joint pain.

With each new indication comes the potential to increase sales significantly. In 2010, for example, Cymbalta was approved for chronic lower back and knee pain, an indication that may have increased sales by $500 Million, a 16% increase over the $3.07 Bn in sales for Cymbalta in 2009 (read, for example, "Cymbalta: A Sweet ROI for Chronic Pain Indication").

But a 16% increase in sales is paltry compared with a 50% increase in sales that is possible when the FDA approves a drug for use in children under the Best Pharmaceuticals for Children Act, a statute that created the incentive for drug makers to test the products in young patients. For Lilly, a 6-month extension of market exclusivity for Cymbalta could give Lilly more than a $2 Billion windfall (in April, 2012, Lilly reported that first-quarter sales of Cymbalta rose 23% to $1.11 billion).

I'm sure the intent of the law was to make it possible for physicians to prescribe drugs for children based on evidence that the drugs worked in children. To offset the cost to drug companies to run trails to prove efficacy, Congress allowed 6 months of additional exclusivity during which those costs could be recouped. In the case of Cymbalta, children do not benefit and Lilly more than recoups the cost of pediatric trials, which involve perhaps only a few hundred subjects.

Purdue Pharma, however, claimed it lacked resources in 2004 when it abandoned a pediatric Oxycontin clinical trial requested by the FDA. Only now -- when Oxycontin is a mere year away from losing market exclusivity -- is Purdue pursing such a trial (see "After Delay, OxyContin’s Use in Young Is Under Study"). Sales of Oxycontin reached $1.7 billion (in the U.S.?) in 2004.

It is too soon to know if the Oxycontin pediatric trial will demonstrate any effectiveness in treating children under 12. One thing that is certain, however, is that street use of Oxycontin by children and young adults is deadly. If extended market exclusivity can help prevent illegal diversion of even cheaper generic versions of Oxycontin, then I am all for it no matter what the clinical trail results!