FDA announces new “Purple Book” for biological products

Similar to the pharmaceutical “Orange Book,” FDA has recently published the first edition of the “Purple Book” of biological products, which is intended to provide the regulatory community with information on the interchangeability of biosimilars.

The book is divided between two sections: products approved by the Center for Drug Evaluation and Research (CDER) and products approved by the Center for Biologics Evaluation and Research (CBER), and contains information such as the BLA number, product name, date of licensure, reference product exclusivity date, withdrawn, and more. In addition, FDA has proposed a four-tier assessment for biosimilar interchangeability, which presents the implication that not all products approved through the 351(k) biosimilar process will be considered interchangeable by the agency’s standards.

Although the U.S. market for biosimilar products is relatively small, FDA expects to see many additions to the Purple Book in the near future.

Click here to read Alexander Gaffney’s full article from RAPS.org.

FDA releases final guidance on companion diagnostics

FDA has recently released a final guidance document on in vitro diagnostic (IVD) companion diagnostic (CDx) products, which are used in conjunction with therapeutic or biological products to maximize effectiveness based on the genetic characteristics of a patient or population. Companion diagnostic products have become more common in the past few years and provide great benefits to both regulators and industry.

Regulators find that diagnostics make it easier to determine which patient populations will benefit, and reduce the risk of drugs being used improperly or on untested patients. In turn, this information helps regulators see who could potentially benefit from a drug and why, ultimately simplifying the approval process for drug manufacturers.

The final guidance provides clarification on policies from the original draft guidance that may have been unclear, but is otherwise the same. According to the guidance, although FDA may approve some drugs without a companion diagnostic device, “in most circumstances an IVD companion diagnostic device and its corresponding therapeutic product should be approved or cleared contemporaneously by FDA for the use indicated in the therapeutic product labeling” in order to ensure safety and efficacy.

To read Alexander Gaffney’s full article on raps.org, click here.

FDA proposes new regulatory framework for Lab-developed Tests

Through a recent draft guidance, FDA has proposed a new risk-based regulatory framework for Lab-developed Tests (LDTs), comparable to existing policies for in vitro diagnostic devices (IVDs).

Historically, LDTs have been developed at low-risk for the diagnosis of rare conditions with the intent to be used within a single organization, and therefore have not been required to obtain FDA approval as IVDs have. The agency has recently noticed an increase in complexity among LDTs, which raises the risk of inaccurate diagnoses, and has ultimately driven FDA to pursue more strict regulation.

On July 31, FDA submitted the guidance, Framework for Regulatory Oversight of LDTs, proposing a risk-based system for regulation. Those classified as “low risk” or intended to diagnose rare diseases will be exempt from most of the regulations, while high and moderate risk LDTs will be subject to more strict requirements.

  • Low-risk (Class I): must meet FDA requirements for registration, device listing, and adverse event reporting.
  • Moderate-risk (Class II): must meet all Class I requirements and begin reporting adverse events within six months of the final guidance. Class II devices will also need to go through premarket review beginning five years after the guidance is finalized.
  • High-risk (Class III): will also need to begin reporting adverse events within six months and those devices with the “highest risk” will also require marketed review beginning one year after the guidance, while the remaining “high-risk” devices will be reviewed over the course of four years.

Following the guidance submission, various medical groups, politicians, and industry representatives have expressed concerns with FDA’s approach; many noting the importance of timely, and innovative diagnostic technologies for quality patient care.


To read Alexander Gaffney’s full article on RAPS.org, click here.

Read Andrew Pollack’s article in the NY Times here.

Also read Varun Saxena’s article on fiercemedicaldevices.com here.

Pearl Pathways sponsors Indiana Life Sciences Conference Series

life sciencesPearl Pathways is proud to sponsor of the 2014-2015 Indiana Life Sciences Collaboration Conference Series, presented by the Kelley School’s Center for the Business of Life Sciences. These conferences provide an opportunity for various industry professionals to discuss important business strategies and solutions to promote the advancement of the life sciences field.

Please join us for this year’s first conference on September 12th entitled An Update on the FDA and Global Regulatory Bodies, where a panel of experienced industry professionals will discuss the potential affects of new approval procedures and quality compliance requirements.

What: An Update on the FDA and Global Regulatory Bodies

Where: IU Robert H. McKinney School of Law, 530 W. New York Street, Indianapolis

When: September 12, 2014 8:00am-3:15pm

Click here for the registration link.


To learn more about the Indiana Life Sciences Conference Series, click here.

Company receives FDA warning letter for social media claims

FDA recently issued an unusual warning letter to a dietary supplement company for unapproved marketing claims, with specific reference to the company’s social media use. The letter explains that under federal law, dietary supplements cannot claim to “treat or cure a specific disease or condition,” and because the company had marketed their products as such, they fall subject to FDA’s regulations for pharmaceuticals.

Throughout the letter, FDA references numerous claims made by the company via social media outlets such as Facebook and Twitter, including the action of “liking” unapproved testimonials from third parties. For example, FDA cited the company for “liking” a woman’s comment on Facebook that read: “It is the best thing for my granddaughters’ bronchitis.” The warning letter states that such claims provide “evidence of intended use in the form of personal testimonials recommending or describing the use of products for the cure, mitigation, treatment, or prevention of disease.”

FDA has since released a draft guidance document outlining the requirements and limitations for the use of Internet and social media platforms in FDA regulated industry.

To read Alexander Gaffney’s full article on raps.org, click here.

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.