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 The information gathered at the workshop may aid to the development of new draft guidance and standards to ensure patient safety and support innovation.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 raps.org 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 raps.org 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 raps.org 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 fiercemedicaldevices.com 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 fooddruglaw.com 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 medcitynews.com 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.

World drug industry regulators to form a coalition

Fdanews.com just published an article on the possibility of FDA and other global regulatory bodies forming a coalition called the International Coalition of Medical Regulatory Authorities (ICMRA). The goal of the ICMRA is not to develop identical standards, but to provide the world with “high-level, strategic advocacy” on quality. This idea comes from FDA, EMA, and Health Canada sharing data on quality inspections of industry facilities. ICMRA has been an idea for years, but there are still some major issues to overcome before they start the coalition. To read the full article click here.

FDA to increase foreign facility inpections

Zachary Brennan from in-pharmatechnologist.com covered FDA’s plan to increase foreign facility inspections. FDA has made inspecting high-risk firms a top priority not just in the United States but also overseas. This is not new for FDA as they planned on visiting 750 high-risk firms in 2013,  but they were actually able to visit 808. Out of those 808 visited, 43 warning letters were issued. To read the full article click here.

Push for FDA to allow children with severe illness access to unproven drugs

John Carroll from fiercebiotech.com just published an intriguing article on recent efforts by parents of children with severe illnesses including Duchene Muscular Dystrophy (DMD) in the wake of a recent FDA denial for compassionate use.  Public relations efforts including flash mob demonstrations and petitions to FDA for pilot studies have been used.  As John Carroll shares, “There are no easy answers here. Just hard questions.” To read the complete article click here.