Is FDA outnumbered in the fight to regulate medical apps?

There’s an app for just about everything, but how do you know which one to trust? There are nearly 80,000 medical apps available to the public; however, very few are tested and regulated by FDA, according to Varun Saxena’s article on  As a result of the draft guidance released by FDA last year, the agency has decided not to use its regulatory authority on some lower-risk medical apps.

Because of this lack of regulation and testing, some apps with misleading information have slipped through the cracks. For example, a 2013 article on JAMA Dermatology’s website cited three apps that falsely diagnosed images of melanomas as benign more than 30% of the time. Such findings are alarming to industry and medical organizations, who are pushing FDA to increase regulation. For now, it is important for the public to understand: FDA is outnumbered by medical apps, the majority of which cannot be trusted just yet.


To read the full article, click here. Need help in determining how your medical app is regulated?  Contact us  at

FDA launches openFDA initiative

FDA has launched openFDA, a new “digital strategy” initiative intended to make government data and information more publicly accessible as covered by Alexander Gaffney of The initiative began in January 2014 with the introduction of, a website containing “open APIs (application programming interfaces), raw data downloads, documentation and examples, and a developer community of an important collection of FDA public datasets.”

Although it is still in the beginning stages of development, the website will enable healthcare and regulatory professionals to access FDA’s data without having to send hundreds of Freedom-of-Information Act (FOIA) requests. The ultimate goal of the openFDA initiative is to provide regulatory and adverse event data with the click of a mouse.

To read the full article, click here.

Google Glass, an emerging healthcare technology

The general public has been swooning over Google Glass since the introduction of the Explorer program last year, in which people could apply to be “the first to make, tinker, create, shape, and share through Glass.” A significant amount of these applications came from doctors and hospital affiliates wanting to incorporate the technology into their practice. Joseph Keenan’s article on explains the experiences and concerns of some doctors who have already begun working with Google Glass.

The technology associated with Google Glass allows doctors to view medical images, hold video conferences, stream operations online, and record what they see, all while performing a procedure. Additional software is currently in process to enable doctors to view a patient’s vital signs, medical history, lab results, and surgical checklists. While most agree this technology would be useful in the future of healthcare, there are still major privacy and safety concerns. Many hospitals and clinics have even decided to ban Google Glass pending FDA approval to avoid HIPAA non-compliance issues and safety risks.

Despite the risk factors, Google Glass presents medical practitioners with a unique opportunity for education and innovation. Keenan shares that one doctor, Dr. Selene Parekh, has been using Glass for over a year to record his orthopedic surgeries at Duke Medical Center. His goal is to be able to broadcast these surgeries as a learning tool for other surgeons in countries that may not be as up-to-date.  In another case, Dr. Paul Szotek, a trauma surgeon at IU Health Methodist Hospital here in Indianapolis, has been using Glass to give students a first-person perspective on medical procedures.

To read Joseph Keenan’s article, click here.

To read the article including Dr. Szotek’s work, click here.

FDA announces a public discussion on 3-D printing considerations

Leslie Kux, Assistant Commissioner for Policy at the Federal Register, posted an event notice regarding a public workshop on “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3-D Printing,” hosted by FDA. The intention of the workshop is to provide a forum for discussion on technical challenges and solutions of 3-D printing.

3-D printing, or additive manufacturing, is a technique used to create devices by layering necessary material based on a computerized model or blueprint. This technique allows designers to make quick alterations for prototype iteration or production of multiple product designs. Combining this technology with a patient’s own medical imaging, anatomically matched devices or surgical guides can be created.

FDA has already received submissions for additively manufactured medical devices and is forecasting substantial growth in the industry over the next ten years, which is motivation for hosting this workshop. FDA is seeking the perspective of stakeholders by discussing scientific and technical challenges associated with additive manufacturing. The information gathered at the workshop may aid to the development of new draft guidance and standards to ensure patient safety and support innovation.

To read the full event notice, click here.

Closing the gap in the US drug import system

Alexander Gaffney of posted an interesting article regarding the current standing of the drug import system. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA may prohibit the import of any drug that has not been approved in the United States. Consequently, FDA is often required to either deny the product or detain it for further processing. This requirement presents a loophole to exporters: in the event that their product has been refused by FDA, its sponsor may request to have the drug returned (even misbranded or counterfeit drugs) and essentially gain the opportunity to resend it with a greater chance of passing inspection.

FDA’s major concern regarding these imports is the negative impact on consumer health because of misbranded dietary supplements and counterfeit drugs. In fact, FDA estimates that anywhere between 20 and 100 million packages containing drugs are imported into the U.S. each year, many from questionable online pharmaceutical sources.

In an effort to solve this issue of imported drugs, a proposition has been created granting FDA authority to destroy any refused drug without providing its sponsor an opportunity for return as long as the value of the drug is less than $2,500. In this case, the owner of the drug would then receive a notice of intent to destroy from FDA.

To read the full article, click here.

FDA completes rewrites of device pre-submission guidance

Alexander Gaffney from released an interesting article on FDA’s completion of the rewrite of device pre-submission guidance. FDA issued a guidance document to outline the changes and why these meetings are so important. They believe that the meetings offer a way to identify, clarify, and solve any obvious potential issues before the process starts. Also contained in the guidance are appendices that are associated with specific types of applications. To read the full guidance click here. To read the full article click here.

FDA productivity gap an issue?

Alexander Gaffney from wrote an intriguing article on productivity gaps that are haunting FDA and the drugs that are in great need of approval. The Manhattan Institute for Policy Research (MIPR) created a report to objectively examine FDA’s speed on reviewing products. It was found that a wide variety of approval times and review cycles existed across FDA divisions.  Check out the below chart from Gaffney’s blog for a sample of the data. To read the full article click here.

Chart for blog

New proposal from FDA on fast tracking medical devices

Varun Saxena from wrote an interesting article on the proposed plan of Expedited Access PMA (EAP). The FDA talked about how EAP is not a new path to market but a collaborative approach to facilitate product development under existing FDA guidelines. It is targeted for a very specific type of high-risk medical devices and allows the company to interact early and on a regular basis with FDA.  Quoted in the article was CDRH Director Jeffrey Shuren, “We are excited to offer a proposed program for expedited access for certain high-risk medical devices.” To read the full article click here.

FDA held hearing on Over-The Counter drugs, taking comments until May 12th

Raqiyyah Pippins and Katie Riley from wrote an informative article on FDA’s hearing on Over-The-Counter (OTC) drugs. The hearing comes at a period where there is a lot of frustration with the monograph process and FDA’s position on novel modes of delivery for certain ingredients FDA is requesting that people communicate the strengths and weaknesses of the existing OTC review process and is accepting comments until May 12th and will release a transcript of the hearing on April 25th. To read the full article click here.

Orphan drug approvals surge

On January 4th, 1983 President Ronald Reagan signed into effect the Orphan Drug Act. For over 30 years, orphan drug development has grown in volume, and has had a major impact on the biopharma and diagnostics industries. With advancement in technology including increased development of novel companion diagnostics as well as the mapping of the human genome, orphan drug approvals by FDA have continued to rise. New data has been released showing that 2013 was a big year for orphan drug approvals.  In 2011, FDA approved 26 orphan drugs. The number dropped slightly in 2012 g to 25, but rebounded in 2013 to a record 31.  Orphan drug designations were also high in 2013 reaching a record breaking 260.

It is estimated by PHRMA in a 2013 Medicines in Development report entitled “Rare Diseases: A Report on Orphan Drugs in the Pipeline,” that 30 million Americans have one of the 7000 diseases deemed rare.  Rare disease is defined as one affecting under 200,000 people in the United States. Further, this report estimated that there were 452 medicines and vaccines in development for rare disease in 2013. To review this report, click here.  To review a recent article in covering the surge in orphan drug development and approvals, click here.

Pearl Pathways has the pleasure of working with several of our clients on developing the appropriate regulatory strategy, executing global regulatory filings, and assisting with clinical trials for orphan drugs.   Contact us if you need assistance with your orphan drug or device.

We anticipate that this focus on orphan drug development will continue among both large pharm and small biotechs. Navigating these diseases in small patient populations is complex and can be daunting, but new technologies and the regulatory landscape have made it a bit easier to impact rare and debilitating diseases.