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FDA Compliance

Tougher Quality Management Enforcement Possible by FDA

New regulations on combination products, and an unknown future as new chair appointment still pending

Published: Tuesday, March 7, 2017 - 13:03

Quality management, always an FDA focus during inspections, could become even more important in 2017 as FDA priorities take shape.

In December 2016, Director Janet Woodcock laid out some of the broader goals for 2017 around the same time Congress approved the epic 21st Century Cures Act. If all goes according to plan, the FDA will have more funding to do its job—including more inspections of life sciences manufacturers.

The 21st Century Cures Act gives the FDA a bonus of $500 million over 10 years to further fund an initiative to use real-world evidence in regulatory decisions. That makes it all the more important for manufacturers to have a strong document management system in place to be able to organize, access, and have the ability to provide detailed data to the agency if requested.

What else can be done with $500 million? Funds from the 21st Century Cures Act will allow the agency to increase compensation in an effort to attract more reviewers. More reviewers equals more scrutiny, experts generally agree.

The agency also issued a number of proposed and final rules in 2016 that signal some of its direction in 2017.

In a proposed rule expected to be published in April 2017, the FDA said it would replace current requirements for reports submitted on investigational new drug (IND) applications. It would largely mirror existing global standards for the format, content, and timing of the submissions.

In late 2017 it is expected that the FDA will finalize a rule to amend post-market safety reporting regulations. The FDA has been contemplating this for more than a decade. This rule will feature helpful definitions of new terms and revised reporting deadlines.

Listed as a long-term action for 2017, the FDA plans to propose “economically significant” regulations; these would define conditions that would exempt compounders from fulfilling certain requirements for their drugs.

Combination products: five post-market safety report elements

Quality management professionals should take note of to a recently issued final rule. Most of this rule went into effect at the end of January 2017. Life sciences manufacturers have a few important adjustments to make.
1. Which post-market safety report to submit. The type of post-market safety report required for combination products will be based on whether the products was approved through a drug, biologic, or device application.
2. Reports based on constituent parts. Additional reports will be based on the constituent parts of the combination product. These include malfunction reports if the product includes a device; field-alert reports in the case of a drug; or biological product-deviation reports, as suggested by public comments following the rule’s initial proposal in 2009.
3. Safety information shared within five calendar days. Sponsors of different parts of a combination product must also share safety information with each other within five calendar days, including events involving death, serious injury, or other adverse events.
4. Periodic safety updates to FDA. Sponsors will now be required to include a summary and prove they understand data cited in previously submitted reports, such as five-day and malfunction reports, in their periodic safety updates to the FDA. Products approved under medical-device applications do not have to make periodic reports. Broadly speaking, this applies to combination products approved under a new drug application (NDA), abbreviated new drug application (ANDA), or biologics license application (BLA).
5. Records kept for at least 10 years. Combination product applicants must maintain records relating to their post-market safety reports for the longest required record-keeping period applicable to the combination product. Currently, that’s at least 10 years.

2019: electronic submission of MEIs

There are new requirements and implementation regarding valid electronic submission of manufacturing establishment information (MEIs), according to a guidance that permits pharmaceutical manufacturers to streamline required information about the manufacturing establishments. The FDA hopes the reorganization initiative will help eliminate some of the potentially outdated and erroneous information sometimes retrieved from other agency files.

In addition, sometime in 2019 MEIs contained in NDAs, ANDAs, and BLAs will only be accepted through electronic submission. Manufacturers still using a manual document management process should implement an automated document management system created with FDA compliance in mind.

Does your document management program incorporate the industry’s best practices? Attend this AssurX webinar to find out.

FDA initiatives amended by new FDA chair?

Of course, some of these initiatives could be amended if President Trump chooses a new FDA chair whose intention is to move the agency in a significantly new direction. Although Trump has not made an official choice yet, some have placed Jim O’Neill at the top of the list. O’Neill, a managing director at Mithril Capital Management, has suggested gutting the FDA’s responsibility to determine whether new medicines are effective before approving them for sale. “Let people start using them, at their own risk,” he said in a 2014 speech to a biotech group.

This year will be one of uncertainty for medical device, pharmaceutical, and general life-science manufacturers and service providers. New requirements plus uncertain direction from an as-yet-unknown FDA commissioner means your quality management department needs to be proactively prepared for just about anything. No more manual quality management processes. An automated and robust regulatory compliance and quality management system can provide an extra layer of protection against overall uncertainty or more stringent FDA enforcement.

First published Jan. 23, 2017, on the AssurX blog.


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AssurX Inc. develops quality management and regulatory compliance software solutions to help companies in any industry exceed quality expectations, ensure compliance, manage risks, and better govern their enterprise. AssurX solutions securely handle manufacturing defects, complaints, change control, regulatory compliance, supplier quality, audits, risk, corrective and preventive actions, and more.