Regulatory Focus™ > News Articles > RegBits: 5 Things to Know About Healthcare Product Regulation Today (18 September 2014)

RegBits: 5 Things to Know About Healthcare Product Regulation Today (18 September 2014)

Posted 18 September 2014 | By Alexander Gaffney, RAC

RegBits: 5 Things to Know About Healthcare Product Regulation Today (18 September 2014)

Welcome to RegBits, a new way to get an at-a-glance look at important regulatory news stories. Today's top stories include new funding for an FDA regulatory science initiative, a Senate bill would make changes to an over-the-counter approval pathway, AdvaMed slams an FDA proposed rule on devices, GPhA wants changes at FDA's Office of Generic Drugs, and CDER goes meta with  a MAPP on MAPPs.

FDA to Continue Funding C-Path

The Critical Path Institute (C-Path), a drug development accelerator program supported by the US Food and Drug Administration (FDA), will continue to receive funding under a five-year contract worth as much as $10.5 million, C-Path announced this week.

The funding was first announced in August 2013 as part of a broader effort to develop new clinical data standards for hepatitis C, diabetes, lipid-lowering drugs and QT studies, as well as other disease areas. As FDA explained at the time:

"The lack of standardized data affects CDER's review processes by curtailing a reviewer's ability to perform integral tasks such as rapid acquisition, analysis, storage, and reporting of regulatory data. Improved data quality, accessibility, and predictability will give reviewers more time to carry out complex analyses, ask in-depth questions, and address late-emerging issues. Standardized data will allow reviewers to increase review consistency and perform evaluations across the drug lifecycle. This will enhance the Center's performance across key drug regulatory functions and ongoing business operations, including premarket review, post-market safety, oversight of drug quality, and oversight of drug promotion."

The latest round of funding, worth $2.1 million, will "support C-Path's collaborative approach and ongoing, groundbreaking work to improve and accelerate the development and regulatory review of drugs," the organization said.

(C-Path) (BioCentury)

Sunscreen, TEA Bill Sees Passage in Senate

The US Senate yesterday voted in favor of the Sunscreen Innovation Act, a bill which seeks to overhaul the Time and Extent Application (TEA) process and remove barriers which have long delayed the approval of sunscreen ingredients which have long been marketed outside the US.

Though the bill has already seen passage in the US House of Representatives, the Senate version of the bill has major differences relative to its House counterpart, requiring it to once again be voted on by the House of Representatives (or be subject to a conference committee between the Senate and House intended to resolve differences in the bills).

The bill was passed by unanimous consent and, if passed by the House, is expected to be signed into law by the president. However, the bill may not see final passage for several more weeks, if not months. Congress is expected to soon adjourn so that members can return to their districts and campaign for re-election. As The Tan Sheet notes, "The legislation likely will have to wait for the lame duck session."

(The Hill) (The Tan Sheet-$)


The generic pharmaceutical industry's trade group, the Generic Pharmaceutical Association (GPhA), is calling on FDA to make improvements to the Generic Drug User Fee Act (GDUFA), a user fee program first passed in 2012 as part of the Food and Drug Administration Safety and Innovation Act (FDASIA).

The program, now in its second year of existence, is being eyed for improvements by both industry and FDA. While FDA has maintained the program has already led to "significant improvements," it has also floated some ideas on ways it could be improved, and called on industry to provide other ideas as well.

Now GPhA is answering that call, saying that FDA should be working harder to eliminate an "enormous and growing backlog" of generic drug applications, known as Abbreviated New Drug Applications (ANDAs) and supplemental ANDAs. In addition, GPhA says it wants more interaction and advice from FDA, saying the regulator's lack of transparency during the review process "reduced predictability for applicants."

Other recommendations include improving predictability and consistency at the Office of Generic Drugs, implementing a new channel for informal contact, and making changes and clarifications to newly released guidance documents on the ANDA submission and approvals process.

(GPhA Statement) (GPhA Recommendations)

AdvaMed on Reclassification

A US trade group representing medical device companies is blasting a March 2014 rule proposed by FDA that would make it easier for the agency to classify and reclassify medical devices according to risk. The rule, Proposed Rule on Medical Device Classification Procedures, established five categories for high-risk, Class III devices which would require the use of a Premarket Approval Application (PMA) to reach the market:

  1. devices that present known risks that cannot be controlled
  2. devices for which the risk-benefit profile is unknown or unfavorable
  3. devices for which a full review of manufacturing information is necessary
  4. devices for which premarket review of any change affecting safety or effectiveness is necessary
  5. combination products

However, in comments submitted to FDA, the trade group AdvaMed claims the rule would upend FDA's longstanding risk classification procedures and "undermines the procedural protections Congress put in place."

"While the revisions are set forth as 'clarifications' to 'terms related to classification and reclassification', the Agency is proposing revisions that are both unnecessary and concerning," the group continued, adding that "the proposed revisions to the Class III definition conflicts with the current statutory classification mechanism," also known as the De novo process.

(AdvaMed Comments)


There's no regulation quite like meta-regulation, and FDA's latest Manual of Policies and Procedures (MAPP) is no exception. The document, Developing and Issuing MAPPs for CDER, describes the process of how FDA's Center for Drug Evaluation and Research (CDER) develops, revises, recertifies, transfers, clears, maintains and cancels its MAPPs.

For the unfamiliar, MAPPs are essentially guidance documents intended for FDA staff, and contain information on everything from the review of drug applications to the proper use of CDER's copy machines.


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