Overview of Plan

This Food and Drug Administration (FDA) retrospective review plan is part of the larger Department of Health and Human Services (HHS) proposal. HHS indicated that the priorities for the initial retrospective review were limited by departmental resources, so FDA and other agencies identified rules that (1) could be easily modified to address burdens or inefficiencies and (2) should be reviewed because of changing technology or other circumstances.

As a result, many of FDA’s proposed changes focus on paperwork reduction, electronic reporting, improving labeling, clarifying and harmonizing existing requirements, and making updates to rules based on technological advancements.

Major Rules to be Revised

FDA included both existing and proposed rules in its review plan. The rules to be revised cover three substantive areas: the manufacture of medical products, the production and labeling of drugs, and food safety. The agency listed 24 rules for review, 22 of which focus on medical products while two cover food safety. In five separate rules, FDA will allow or require electronic submission of (a) data from regulated entities to agency oversight staff, including safety reports; (b) clinical study data submitted to the agency; (c) electronic registration and listing of drugs and medical devices by manufacturers; and (d) adverse event reporting. Another rule change allows firms to use e-labeling to send prescription information on human drugs and biological products to health care professionals.

Four other rules to be reviewed pertain to current Good Manufacturing Practices (cGMP) for manufacturers of combination medical products, finished pharmaceuticals,¹ drug components, and food producers. Three of the cGMP rule changes are new, and one is a proposed rule FDA published in 2009 that would clarify requirements for producers of products that have drug, device, and/or biological components.

FDA anticipates the cGMP modifications will create flexibility for the affected industries, take recent technological advancements into consideration, improve safety and quality, and help medical industries manage the globalization of drug manufacturing.

The food cGMP revisions will establish greater preventive controls for food facilities in order to reduce the instance of food-borne illness. This revision was triggered by the Food Safety Modernization Act, signed into law on Jan. 4.

As part of its Food Initiative, the agency will be revising and updating its food labeling requirements to provide consumers with more useful nutrition information.

In addition, FDA intends to do a full cost-benefit review of an eight-year-old rule requiring linear bar codes on drug packaging containers. FDA originally estimated that the “Bar Code Rule” would save $93 billion and prevent nearly 500,000 medication errors over 20 years. This review will examine whether the original cost-benefit analysis was accurate and determine whether or not the rule should be updated to reflect technological advancements.

While many of these changes focus on making reporting of information to the FDA easier, some of the electronic-based revisions have important public health benefits. For example, the e-labeling rule will provide up-to-date prescribing information to health care providers who prescribe drugs. This could result in fewer instances of improperly prescribed drugs and the latest information on drug interactions. The rule that allows post-marketing safety reports for human drugs and biologics to be submitted electronically would allow FDA to collect and analyze safety information more quickly. As a result, the agency should be able to spot problem trends and get information to the public more quickly.

The two food safety revisions FDA plans both have important public health implications. As noted, the cGMP revision targeting food manufacturers should enhance safety controls at plants to reduce chances of food contamination. The nutrition labeling revisions will provide more up-to-date nutrition information so that consumers can make better food choices.

Cost Reduction

FDA does not include any cost-savings information in the review plan. The agency is in the early stages of developing many of the rules so it cannot yet estimate benefits and costs. The plan notes, however, the types of savings expected with the implementation of certain rules. For example, FDA suggests that the proposal to switch to electronic reporting for certain medical device requirements will reduce processing time for producers and will allow FDA to be more responsive to submissions of adverse events, decreasing the threat to public health. Similarly, revisions to cGMP rules will improve product safety and reduce the harms to both producers and consumers that result from poorly produced or manufactured products.

HHS includes cost-savings data for a few rules from other agencies (see below), but many of their proposed changes did not include cost savings estimates. As result, the total economic benefit of all of the revisions is expected to be much higher than the sum of the reductions listed below.

Transparency, Outreach, and Public Input

HHS did not undertake a robust public input process compared to the other agencies reviewed, although FDA individually received public submissions through its own comment process.

According to HHS, a request for comment was posted in the Federal Register on April 23, 2011, and 21 comments were received by the close of the comment period on May 12, 2011. A second HHS comment period was published in the Federal Register on June 6, requesting comments by June 30, but no public submissions were posted to the docket on Regulations.gov. While HHS did attach a summary of public comments to both its preliminary and final plan, the lack of detail provided makes it difficult for the public to know who submitted comments and understand the full range and impact of recommendations submitted. The department appears to have left much of the public outreach and comment procedures to its individual agencies, of which FDA produced the most thorough public input initiative.

FDA published a notice in the Federal Register on April 27 and accepted comments for two months. The online docket available at Regulations.gov contains 70 public submissions. Of these, about 40 were submitted by individuals or physicians and about one-third were from pharmaceutical manufacturers, industry groups, associations, etc. Fewer than 10 comments were submitted by health advocacy organizations (which included Friends of Cancer Research, Susan G. Komen for the Cure, and Juvenile Diabetes Research among others).

In addition, as part of its transparency initiative, FDA created a webpage that lists all of the regulations proposed for review and allows the public to follow agency efforts to improve regulations through regulatory review.

Public Comments

Most of the comments in the FDA docket involved the broad initiatives identified in the HHS preliminary plan, including reducing the burdens imposed by medical device regulations, reviewing cGMPs for food and drugs, and improving pre-market review for medical devices. Commenters were generally supportive of efforts to update regulations to reflect electronic submissions and streamline the reporting process. For example, the Biotechnology Industry Organization (BIO) requested that FDA approve electronic inserts instead of paper labeling for human drug and biological prescription drugs. FDA has included this change in its list of revisions.

Public submissions also contained a number of suggestions for clarifying or consolidating reporting requirements. The Pharmaceutical Research and Manufacturers of America suggested that FDA eliminate redundant reporting in Development Safety Update Reports and New Drug Application annual reports. Many commenters, such as the American Association for Clinical Chemistry, suggested changes to the medical device classification process, such as an automatic review for reclassification for devices meeting certain criteria. CGMPs for food and pharmaceutical manufacturers were another common topic in the comments, but the recommendations for agency action varied. Some commenters, such as BIO, argued that cGMPs are overly burdensome and should be revised, while others merely suggested that they be reviewed to ensure alignment with the GMPs of other countries.

Ongoing Retrospective Review and Other New Initiatives

HHS indicates that the retrospective review process is ongoing, and that it will expand its existing review process to include retrospective reviews. The current process includes reviews that comply with Regulatory Flexibility Act requirements, yearly reviews of appropriations for Medicare payments, internal determinations of the need for rule revisions, and public petitions. One of the agency’s immediate next steps is a review of regulations that were not included in the initial retrospective review and have been on the books for at least five years, a process that HHS expects to complete by the end of 2011.

In conjunction with E.O. 13563, HHS plans to improve transparency in its regulatory process and increase public access to agency actions. The primary vehicle for this change will be a dedicated “reg room” website that the public can link to from the HHS main site and that provides visitors access to all steps of the regulatory process including existing regulations, comment submission pages for proposals, and supporting data and other materials. The agency will also improve the usability of Regulations.gov by standardizing the types of documents included in the docket, maintaining one docket for a regulatory action from proposal to completion, and providing easily understandable summaries of regulations for public consumption.

In order to address current shortcomings in agency procedures, HHS will create two taskforces to study potential improvements. One will look at ways to increase interaction with the public during rule comment periods and the retrospective review process. The taskforce, which is scheduled to complete its report in March 2012, will examine the potential of using podcasts, webinars, and other technologies to improve outreach. The other taskforce will focus on improving regulatory analysis. This team is charged with improving the quality of analysis within the department and ensuring that agencies work together to share data and expertise. This group should complete its report by December 2011.

Other Changes to the Final Plan

HHS had some of the most significant changes of any agency between its preliminary and final plans. First, the agency added “streamline or eliminate unjustified costs and burdens” to the list of principal goals. The wording of the description of the new goal indicates that HHS may have been reluctant to put a significant emphasis on burden reduction because it detracts from the agency’s overall mission of protecting the public.

Second, the preliminary plan did not contain specific estimates for cost-savings or burden-reduction. The final HHS plan includes estimates for some of the major rules to be affected. This is likely in response to the Office of Management and Budget memorandum requesting agencies to include specific cost and burden reduction information in the plans.

¹Current good manufacturing practices are minimum standards for pharmaceutical manufacturers enforced by the FDA. cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. A rule proposed in 2009 to clarify and codify the cGMP requirements for combination products (combinations of a drug, device, and/or biological product) is now in the final rulemaking stage. The final rule would not require manufacturers of combination products to fully implement cGMP regulations for both drug and device products, but would allow manufacturers to implement either the drug cGMP or device quality system regulation if both would apply to their manufacture of the combination product and they incorporate certain provisions from the other set of cGMP regulations.