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Regulatory Reform: Companies and Industry Groups Offer up a Wish List of CDER, CDRH Changes

Posted 09 February 2018 | By Zachary Brennan 

Regulatory Reform: Companies and Industry Groups Offer up a Wish List of CDER, CDRH Changes

Johnson & Johnson (J&J) and Abbott, as well as industry groups PhRMA, BIO and AdvaMed have singled out their priorities related to the US Food and Drug Administration’s (FDA) call to modify, repeal or replace regulations, according to comments released Thursday on the docket.

J&J compiled a list of seven priorities submitted to both CDER and CDRH, including reforms to ease the way in which manufacturers communicate information not on a product label, post-approval regulations that allow changes to a label without FDA approval, reducing conflict of interest barriers for FDA advisory committees (which PhRMA also called for) and increasing the use of electronic, rather than paper, labeling.

J&J also discusses FDA’s decision to pause a program for the voluntary reporting of quality data through an FDA portal after industry called on the agency to hit the breaks on it.

"We are aligned with FDA that manufacturers should collect and analyze quality data. However, each company collects and analyzes data in its own way and conforming to a one-size-fits-all approach requires burdensome process changes. The Food, Drug, and Cosmetic Act does not authorize FDA to require companies to collect and submit these data according to prescribed formats. We are aligned with the current pause in this program for additional stakeholder input and suggest that instead of requiring manufacturers to submit quality data and metrics to the Agency this data should be available for review during inspections," the comment says.

PhRMA also called for changes to FDA guidance on human factors studies in its CDRH comments, while BIO called for changes to regulations on genetically engineered animals.

Reciprocal Approvals and Inspections

J&J also suggests that FDA allow for reciprocal medical device approvals with the EU for a "breakthrough life-saving class III medical device…Additional data collection should take place post-marketing in order to ensure patient access to needed treatment options while upholding a strong commitment to safety. FDA regulations at 21 CFR 814 Subparts B and C should be revised to reflect this approach."

Abbott, meanwhile, calls on FDA to withdraw a proposed rule on the electronic submission of labeling for certain home-use devices, which it says "is redundant because device labeling is required to accompany medical devices placed into commercial distribution. Further, device labeling is widely available to users and many manufacturers of home-use devices provide labeling information for products through their websites."

Device industry group AdvaMed, meanwhile, offered 19 recommendations, covering everything from revisions to the use of symbols in labeling rule to asking FDA to consider conducting a paper review rather than an on-site pre-approval inspection.

"Increased use of review via manufacturing section of a PMA would save significant time. Preapproval inspections are intensive in time and resource burden," the group said, suggesting a change could save $10 million.

CDER Comments

In the CDER docket, PhRMA’s 127-page comment featured numerous priorities on manufacturer communications, discussing the agency’s "overly restrictive approach that limits truthful and non-misleading communications," as well as general issues, such as IND safety reporting, and good manufacturing practice requirements for combination products and release requirements for biological products.


Review of Existing CDRH and information collection requirements

Review of Existing CDER and information collection requirements

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