New performance goals to expedite FDA responses for generics manufacturers

With the introduction of two draft guidances, FDA has set new performance goals for the regulatory submission process for generic drug manufacturers. Over the course of a three-year period, the agency will begin to implement these goals and eventually reach a point where almost all submissions for prior approval supplements (PAS) will receive action within six months and Abbreviated New Drug Application (ANDA) amendments will receive action within ten months. By promising expedited response times, FDA is hoping to motivate generics manufacturers to submit quality applications with minimal revisions.

The new performance goals will begin to affect regulatory applications with a submission date on or after October 1, 2014. FDA response timelines will be determined by a three-tier system that will divide any necessary amendments into groups based on complexity.

Read Bryan Koenig’s full article on fdanews.com for more information. Need assistance with your regulatory submission? Contact us at contact@pearlpathways.com.

Regulatory expert warns of “unintended consequences” following new bill

In June 2014, U.S. Congressmen Steve Stivers and Tim Ryan of Ohio introduced the Speeding Access to Already Approved Pharmaceuticals Act, which is currently referred to the House Committee on Energy and Commerce. This Act would require FDA to begin reviewing new drugs within 90 days of approval in the European Union (EU) as part of an effort to reduce “delays in approval for life-saving and life-changing medical treatments.” Many industry representatives, however, have expressed some concerns.

Regulatory expert Matthew Weinberg, CEO of The Weinberg Group says, “there will be a massive number of unintended consequences.” Weinberg begins by explaining the differences between FDA and the European Medicines Agency (EMA). These differences include varying methods for determining the safety and efficacy of pharmaceuticals.  As a result not all products are mutually approved by both agencies.

Weinberg then provides two significant examples of potential “unintended consequences.” First, Weinberg says that by forcing FDA into a 90-day review, the agency will most likely reject the product due to insufficient information, adding that “it’s not their job to get new drugs on the market as fast as possible; it’s their job to protect American lives.” The second issue is that pharmaceutical companies would choose to apply for approval in Europe rather than the U.S., and then force FDA into a 90-day review of the product, which is “unheard of in this country for good reason,” according to Weinberg.

To read Fiona Barry’s full article, click here.

FDA releases final guidance on GUDID with more revisions to come

Back in 2012, FDA proposed to establish a unique device identification (UDI) system to track and identify medical devices in the US. Following the proposal, FDA released a final rule with a complementary draft guidance for a standardized system to be run through their database known as the Global Unique Device Identification Database (GUDID), which serves as an industry resource for product labeling information.

On June 27, FDA issued final guidance on the use of the GUDID with an approach that surprised many industry representatives. Although some changes were made to the final guidance, FDA removed almost half of the content from the draft guidance stating that future revisions would contain more specific details for sections that have yet to be finalized.

To read an article by Alexander Gaffney’s on raps.org explaining the guidance, click here. To review the guidance document on FDA’s website, click here.

Need help with enhancing your UDI processes?  Contact us at contact@pearlpathways.com.

FDA releases social media draft guidance

Alexander Gaffney of raps.org posted an interesting article regarding the use of Internet and social media platforms in FDA regulated industry. Many companies have been using such resources to promote products and answer customer questions; however, FDA has been known to issue warning letters and sanctions for “unapproved” or “misbranded” commentary, leading industry to demand guidance. In response, FDA has released two draft documents outlining the requirements and limitations for the use of Internet and social media platforms among drug and device companies.

Released in June, the most recent draft guidance specifically applies to networks with character limitations such as Twitter and sponsored links via Google or Yahoo. As the guidance suggests, FDA is requiring each individual post to contain “material facts about the use of the product, such as limitations to an indication or the relevant patient population…and at a minimum, the most serious risks associated with the product.” For most companies, the task of generating a promotional message to fit these criteria within a limited number of characters is near impossible. FDA urges these firms to reconsider the use of certain social media platforms in this regard .

To read the full article, click here.

FDA proposing six new rules in the next year

The US Food and Drug Administration (FDA) has significant changes in regulation planned throughout the next year, as shared by Alexander Gaffney of RAPS.org. The article highlights six major proposals, five of which fall under the Drug Quality and Security Act (DQSA) of 2013. The following is a brief description of each rule, in order of anticipated or prior proposal release date:

  • Proposal granting FDA authority to destroy low-value drugs that are refused admission into the U.S. (May 6, 2014).
  • Modification of the list of drug products that may not be compounded as a result of the product’s removal from the market, due to safety and efficacy concerns (May 2014).
  • Rules regarding human drug compounding conditions within 503A and 503B facilities (October 2014).
  • Rule outlining the minimum requirements for good manufacturing practices (GMP) at outsourcing facilities (November 2014).
  • Revision of the current requirements regarding annual reports submitted to investigational new drug applications (INDs) to create consistency with the requirements endorsed by the International Conference on Harmonization (ICH). (March 2015).
  • Final rule establishing national standards for licensing prescription drug wholesale distributors and third party logistics providers (November 2015).

To read the full article, click here.

FDA and industry groups working to bring patient perspective into the regulatory process

Alexander Gaffney of RAPS.org posted an interesting article regarding FDA’s new Patient-Focused Drug Development Initiative, created to obtain patients’ perspectives on the severity of their conditions and the treatment options currently available. The goal is to increase patient involvement in the regulatory process.

FDA isn’t alone with this idea. In addition to PhRMA’s patient initiative that launched in November 2013, the advocacy group FasterCures is forming a Benefit Risk Advisory Council. Council members come from a variety of backgrounds including industry, patient and trade groups, rare disease advocates, academic institutions, and government. FasterCures’ intention with this group is provide feedback from stakeholders to drug developers and regulators.

To read the full article, click here.

FDA releases final guidance on expedited drug approval programs

According to Alexander Gaffney of RAPS.org, FDA has finalized the guidance document regarding its four expedited drug approval programs: fast track designation, priority review designation, accelerated approval, and breakthrough product designation. These four programs are designed for drugs that are intended to treat serious or life-threatening conditions.

Following the release of the draft guidance supporting these programs, FDA received numerous comments and suggestions from industry representatives, which resulted in hundreds of changes to the final document. Some of these changes highlighted in the article include:

  • FDA has committed to rolling reviews for some breakthrough products as well as grant breakthrough products access to priority review.
  • Clarification that just because FDA grants a product breakthrough therapy designation, this doesn’t mean it will obtain approval.
  • A new definition for the term preliminary clinical evidence: “evidence that is sufficient to indicate that the drug may demonstrate substantial improvement in effectiveness or safety over available therapies, but in most cases is not sufficient to establish safety and effectiveness for purposes of approval.”

To read the full article, click here.  Need help with your FDA filings for a product that treats serious or life-threatening conditions?  Contact us at contact@pearlpathways.com .

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 fiercemedicaldevices.com.  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 contact@pearlpathways.com.

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 RAPS.org. The initiative began in January 2014 with the introduction of open.fda.gov, 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 http://www.fiercemedicaldevices.com 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.