FDA moves to reduce cybersecurity threats in medical devices

FDA has released a final guidance document and collaborated with the National Health Information Sharing & Analysis Center (NH-ISAC) as part of their effort to protect patient privacy and prevent cyber-security threats in medical devices. The guidance suggests that manufacturers identify potential security risks and submit action plans to FDA to reduce vulnerability.

FDA’s additional partnership with the NH-ISAC will help foster the relationship between healthcare providers and security experts and provide programs to further minimize cyber-security threats. These threats came to light last year when two Department of Homeland Security researchers discovered a hard-coded password vulnerability affecting approximately 300 medical devices.

Click here to read Patrick Ouellette’s article on healthitsecurity.com. For additional information, read FDA’s final guidance and memorandum of understanding with the NH-ISAC.

New FDA study to examine the effects of distractions in drug ads

FDA has been granted approval to move forward with a May 2014 study proposal to analyze the effects of distractions in drug advertisements. In the study announcement FDA explains, “We hypothesize that distracting audio and visuals during the major statement will decrease risk recall, risk perceptions, and attention to superimposed text risk information.”

To conduct the study, FDA has created two drug advertisements: one with minimal distractions and the other with significant distractions. As each ad plays, the viewers’ eye positioning and movement will be examined to determine if the major risk statement is appropriately recognized.

Click here to read FDA’s study announcement. For additional information, refer to Alexander Gaffney’s article on raps.org.

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and contains information such as the BLA number, product name, date of licensure, reference product exclusivity date, withdrawn, and more.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 proposes to exempt 107 medical devices with new draft guidance

In an effort to simplify the approval process for low-risk medical products, FDA has exempted 107 medical devices from its 510k premarket notification regulations. This list was released as part of the August 1st draft guidance, allowing devices that are “sufficiently well understood and do not present risks that require premarket notification review to assure their safety and efficacy” to be marketed without a 510k submission, given that the device meets all other regulatory requirements.

FDA has granted exemptions for medical devices such as portable air compressors, fluid-filled teething rings, surgical lights, and obstetrical forceps.

To read Joseph Keenan’s article on Fierce Medical Devices, click here.

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.