At the Intersection of Health, Health Care and Policy Cite this article as: Thomas J. Hwang, Jerry Avorn, Daniel Carpenter and Aaron S. Kesselheim Quantifying The Food And Drug Administration's Rulemaking Delays Highlights The Need For Transparency Health Affairs, 33, no.2 (2014):309-315 doi: 10.1377/hlthaff.2013.0564

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FDA Transparency By Thomas J. Hwang, Jerry Avorn, Daniel Carpenter, and Aaron S. Kesselheim 10.1377/hlthaff.2013.0564 HEALTH AFFAIRS 33, NO. 2 (2014): 309–315 ©2014 Project HOPE— The People-to-People Health Foundation, Inc.

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Quantifying The Food And Drug Administration’s Rulemaking Delays Highlights The Need For Transparency

Thomas J. Hwang is an undergraduate student at Harvard University, in Cambridge, Massachusetts.

The Food and Drug Administration (FDA) frequently uses its rulemaking process to establish or modify the way it regulates drugs, medical devices, and other medical products. The federal agency’s rulemaking is controversial because of its perceived complexity, lack of transparency, and lengthy duration. To shed light on the FDA’s rulemaking process, we examined the evolution of significant rules that the agency published during 2000–12 for drugs, devices, and other medical products. We found that the rules’ median time to finalization was 7.3 years, with the pre-rule phase and postreview deliberation within the FDA accounting for the majority of that time. Rules that involved mandatory cost-benefit analyses were associated with an additional delay of approximately two years. We also found that longer review times were significantly associated with a reduction in the stringency of final rules, compared to the originally proposed versions. We recommend improving FDA’s rulemaking by allocating additional resources to increase efficiency and by embarking on initiatives to promote transparency by the FDA and other parts of the executive branch. ABSTRACT

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he Food and Drug Administration (FDA) has broad regulatory and enforcement authority to protect the public health and ensure the safety and efficacy of the nation’s medical products. Like other regulatory agencies, the FDA relies on rulemaking to interpret and implement laws enacted by Congress and the president.1 The FDA publishes rules that establish or modify the way it regulates foods, drugs, biologics, cosmetics, radiation-emitting electronic products, and medical devices.2 The Administrative Procedure Act of 1946 requires federal agencies such as the FDA to provide a notice of proposed rulemaking and a window of thirty to sixty days for the public to comment on the proposed rule. In most cases, the agencies must take these comments into consideration and incorporate a response to them into the final rule that justifies decisions to

Jerry Avorn is a professor of medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, in Boston, Massachusetts. Daniel Carpenter is the Allie S. Freed Professor of Government and director of the Center for American Political Studies, Faculty of Arts and Sciences, Harvard University.

amend the rule or not.3 The Executive Office of the President oversees the regulatory activities of the FDA and other executive agencies.3 Within the Executive Office, the Office of Information and Regulatory Affairs (OIRA) has the primary responsibility for coordinating agency rulemaking, monitoring the effects of federal regulation, and ensuring that regulations are consistent with presidential priorities.4 Under Executive Order 12866, OIRA has ninety days to review federal agencies’ “significant” rules—those expected to raise novel policy issues or have adverse effects on the public health, environment, or economy. OIRA reviews significant rules at two stages: before publication of the proposed rule and after public comments are received but before the rule is finalized. A subset of significant rules—those that are “economically significant” because they are expected F e b r u a ry 2 0 1 4

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Aaron S. Kesselheim ([email protected]) is an assistant professor of medicine at Harvard Medical School and director of the Program on Regulation, Therapeutics, and Law in the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital.

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FDA Transparency to have a large or disproportionate effect on the economy or protected entities as designated by legislation, such as small businesses and tribal governments—are also subject to cost-benefit analyses by agencies such as the FDA. Agencies revise rules based on the OIRA review and then issue either a proposed or a final rule. Since 2000 the FDA has published more than 300 rules dealing with medical products, including rules that tighten the agency’s oversight of medical devices; strengthen procedures for reporting adverse events before and after a product is approved for marketing; and establish standards for product labeling, manufacturing, and performance. For example, a 2004 rule removed ephedrine alkaloid–containing dietary supplements from the market because of concerns about the supplements’ toxicity. Rules in 2008 and 2011 required manufacturers of condoms and sunscreen, respectively, to meet new standards before making certain claims about the products’ effectiveness on their labels. The FDA’s rulemaking process has been controversial. Critics have argued that its slow pace hinders the FDA’s core activities and may even endanger the public health.5,6 As an example, when the FDA took steps toward switching the status of the Plan B drug (also known as the morning-after pill) from prescription to overthe-counter, a former agency official accused the FDA of unnecessarily restricting adolescent women’s access to emergency contraceptives by subjecting the decision to rulemaking.5 In an opinion in the US District Court for the Eastern District of New York, one judge wrote that the agency’s planned consideration of rulemaking in this case “permits the FDA to engage in further delay and obstruction.”7 Rulemaking is critical to health governance and the ability of agencies to implement policy. However, there is limited information about the characteristics of the process. In this study we sought to define the current FDA rulemaking landscape, identify key bottlenecks in the agency’s rulemaking system, and illuminate potential areas for reform.We evaluated significant medical product rules that the FDA published during 2000–12 to examine the rulemaking timeline and process and to investigate how rules changed in response to comments from the public and the Executive Office.

Study Data And Methods Data Collection The annual Unified Agendas of Federal Regulatory and Deregulatory Actions and Regulatory Plans provide data on rulemaking activity across the federal government. We reviewed these data to identify all significant 310

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FDA rules relating to drugs, medical devices, biologics, vaccines, and blood products that were issued during 2000–12. We then reviewed abstracts of the rules we identified and excluded the nonrelevant ones. To ensure that all relevant rules were included, we also checked the identified rules with OIRA’s online database of rules that it has reviewed.8 For each rule in our final cohort, we collected all electronically available records of public comments submitted to the FDA. We also collected drafts of documents with “tracked changes” that provided insight into the changes made during OIRA review from Regulations.gov, the online repository of agencies’ regulatory dockets.9 Data Extraction And Analysis To build a timeline for each rule, we first identified the initiation date from rule preambles; records of congressional hearings, advisory committee meetings, and public hearings; speech transcripts; or the FDA website. Next, we identified the dates of the earliest publication of a draft of the rule by the FDA, OIRA’s review or reviews, and the publication of the final rule in the Federal Register. For economically significant rules, we extracted annualized estimates of costs and benefits from the proposed and final versions. We then assessed changes to the rule’s stringency during its development. Final rules were considered less stringent than their proposed versions if they had a later effective date, applied to fewer entities, or had less burdensome requirements for product labeling or record keeping. We coded an increase in rule stringency as +1, no change as 0, and a reduction in rule stringency as −1. To plot the likelihood of rules’ stringency remaining unchanged, we used a cumulative survival probability plot. We analyzed the nature of the changes requested in public comments using methods previously employed in the literature.10 Fewer than 5 percent of all public comments received by the FDA for the rules in our cohort were available electronically. Therefore, to minimize bias, we limited our analysis to those rules for which at least 75 percent of all comments had been uploaded to Regulations.gov. For each comment, we categorized the author as industry, public interest group, or other, and we coded the requested direction of change on the scale of regulatory stringency described above. We calculated n-weighted averages of these scores and used Fisher’s exact tests to compare the overall direction favored by commenters. We used the nonparametric Mann-WhitneyWilcoxon and Kruskal-Wallis tests to analyze the effects of economic significance, number of public comments, the political party of the

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Rulemaking is critical to health governance and the ability of agencies to implement policy.

president, and the originating division at the FDA11 on the length of the following phases of the rulemaking process: pre-rule deliberation, or the time spent by the FDA to develop a rule from the first known mention of the agency’s intention to do so to the date it submitted the proposed rule to OIRA; OIRA review, including the review of the proposed rule and the review of its final version; and postreview deliberation, the time spent by the FDA after receiving comments from OIRA and the public before issuing the final rule. We used regression models to test for potential interactive effects (for more detail on our methodological strategy, see the online Appendix).12 Statistical analyses were performed using the software Stata, version 12.0, with a twosided α ¼ 0:05. Limitations Our analysis was limited primarily by the inconsistent online availability of key regulatory documents, such as OIRA’s changes to rules and public comments, despite statutory requirements that this information be publicly available. In sensitivity tests, however, we found no statistically significant difference in regulatory characteristics between the rules for which data were available and the rules in our larger sample. In addition, since we focused our analysis on significant medical product rules, our results may not be generalizable to nonsignificant rules or to rules relating to other FDA-regulated goods (such as food or tobacco). Nonetheless, our results are consistent with analyses of other agencies’ rulemaking.13 Our analysis also did not include guidance documents, which do not have the force of law but which observers regard as highly consequential in FDA policy making.14 The development of guidance documents, which may reflect even less transparency than traditional rulemaking, clearly deserves further study. Finally, although there were clear start dates for the development of most rules, the start dates in certain cases were ambiguous. Some start

dates might have been earlier than we noted, which suggests that our results might underestimate the duration of the rulemaking process.

Study Results We identified forty significant rules on medical products issued by the FDA during 2000–12. Those rules were roughly 10 percent of the medical product rules published during that time (Appendix Exhibits 1 and 2).12 Half of the rules were economically significant, and the FDA conducted cost-benefit analyses for them. In nine cases, this was because the rule had an estimated economic impact of $100 million or more. In the remaining eleven cases, there was a statutory requirement for such an analysis. Rules’ Time To Finalization The median time to finalization for these forty rules was 7.3 years (Exhibit 1). Pre-rule deliberation contributed the most time, followed by postreview deliberation and OIRA review. There were no statistically significant differences in either total time or time of individual phases related to which division in the FDA created the rule. Exhibit 2 shows the cumulative distribution of time to finalization for the twenty economically significant rules (those requiring cost-benefit analyses) and the twenty other rules (median time to finalization, 7.7 years versus 5.3 years, respectively; p ¼ 0:04). The economically significant rules also were associated with significantly longer postreview deliberation, compared to the other rules (2.6 years versus 1.4 years, respectively; p ¼ 0:04). Rules’ Evolution To evaluate the evolution of rules from their proposed to final forms, we measured both changes in cost-benefit analyses and changes related to OIRA review and public comments. ▸ CHANGES IN COST - BENEFIT ANALYSIS : The cost-benefit analyses of all twenty of the economically significant rules in our sample provided monetized estimates of costs. However, the methods used to annualize, discount, and aggregate values varied. The cost-benefit analyses for nine of the rules (45 percent) provided monetized estimates of the rules’ benefits; the analyses for two of the rules (10 percent) provided quantified but nonmonetized estimates of benefits. Cost-benefit analyses for the remaining nine rules described potential benefits in qualitative terms, such as potentially allowing valuable therapies to become available sooner. The economically significant rules were estimated to have an aggregate annual cost of $7 billion (range: $0.3 million–$4.9 billion) in 2011 dollars and annual benefits of $11 billion (range: $44 million–$5.2 billion). February 2014

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Times more likely Across the four rules, a request for reduced stringency was 12 times more likely to come from industry than from a public interest group.

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FDA Transparency Exhibit 1 Time To Finalization Of Forty Significant Food And Drug Administration (FDA) Medical Product Rules, 2000–12

Total

Pre-rule deliberation

Postreview deliberation

OIRA review

Duration (years)

SOURCE Authors’ analysis. NOTES The horizontal lines indicate the range between minimum and maximum values. The horizontal bars (or boxplots) indicate the first (left box) and third (right box) quartiles. The vertical lines indicate median values. Pre-rule deliberation is the time spent by the FDA to develop a rule. OIRA review is the time spent by the Office of Information and Regulatory Affairs to review the FDA’s rules. Postreview deliberation is the time spent by the FDA deliberation after receiving comments on proposed rules from OIRA and the public. For more details on these periods, see “Data Extraction And Analysis” in the text.

On average, as rules evolved from proposed to final form, the FDA’s estimated benefits decreased 15 percent, and estimated costs increased 25 percent. For example, in a proposed rule to remove dietary supplements containing

Exhibit 2

Cumulative percentile

Cumulative Distribution Of Time To Finalization Of Forty Significant Food And Drug Administration (FDA) Medical Produce Rules, 2000–12

SOURCE Authors’ analysis. NOTE Half of the forty rules were economically significant; half were not.

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ephedrine alkaloids from the market, the FDA initially estimated the annual benefits as $240– $670 million, with costs of less than $10 million. The FDA subsequently received public comments arguing that the estimated benefits should be lower because of health risks posed by substitute products. In the final rule, the benefits were estimated to be $43–$130 million and the costs to be $7–$90 million. ▸ THE EFFECT OF OIRA REVIEW : As explained above, OIRA reviews significant rules at two stages.We retrieved electronic documents detailing OIRA reviewers’ edits for eight of our forty significant rules. In six cases, reviewers provided comments on a final rule; in two cases, they provided comments on a proposed rule. OIRA reviews resulted in reductions in stringency for three rules and no changes in stringency for the remaining five. For two rules that removed metered dose inhalers containing ozone-depleting substances from the market, OIRA reviewers suggested delaying the effective date by a year. For a proposed rule on manufacturing standards for dietary supplements, the review led to reductions in the rule’s stringency before public comment. Reviewers suggested adding a statement that “to limit the burden to manufacturers,” the FDA would not propose requirements similar to those for food manufacturing in this case.15 ▸ THE EFFECT OF PUBLIC COMMENTS : The bulk of public comments (at least 75 percent) were available electronically for only four of the forty significant rules in our sample (10 percent). Collectively, these four rules were the subject of 190 comments (Exhibit 3). Forty-nine percent of the comments came from industry, 27 percent from public interest groups, and 24 percent from other sources. Across the four rules, a request for a reduction in the rule’s stringency was twelve times more likely to come from industry than from a public interest group (p < 0:001). The final stringency of the rule was correlated with the overall direction favored by public commenters. For example, both industry and public interest groups favored reducing the stringency of a proposed rule on manufacturing standards for cell- and tissue-based products (rule 0910AB28; see Exhibit 3). The final rule was less stringent than the proposed rule. In sensitivity tests, we found no significant differences in regulatory characteristics between these four rules and other economically significant rules.We also found no association between the total number of comments and the total time to rule finalization or length of postreview deliberation (p > 0:20). ▸ COMBINED EFFECTS : The final versions of

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Exhibit 3 Influence Of Public Comments On Delay And Stringency Of Four Food And Drug Administration (FDA) Rules Comments Time to finalization

All (N=190)

Start 2001

End 2003

Percent of commentsa Score No. Score 89 0.129 31 0.037

1997

2004

89

−0.646 42

−0.800

1992

2006

93

−0.074 90

Human Subject Protection 2004 and Foreign Clinical Studies Not Conducted under an IND Application

2008

84

0.130 27

Regulation identifier number Rule title 0910-AC48 Drug Patent Listing and Application of 30-Month Stays on Approval of ANDAs 0910-AB28 Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments 0910-AA94 Labeling for Prescription Drugs and Biologics 0910-AF15

Industry (n=93)

Public interest groups (n=52) Outcome Reduced No. Delayed stringency 3 No No

No. Score 27 1.000

27

−0.474

10

Yes

Yes

−0.544*** 30

0.323*** 33

Yes

Yes

−0.636***

0.833***

No

Yes

9

6

SOURCE Authors’ analysis. NOTES Rule changes were assessed according to whether the FDA delayed the effective date or publication of the final rule (“delayed”) or lowered the rule’s level of stringency (“reduced stringency”). We scored each comment as requesting more stringency (+1), no change in stringency (0), or less stringency (−1). ANDA is abbreviated new drug application. IND is investigational new drug. aComments publicly available and retrieved by the authors. ***p < 0:001

eight of the twenty economically significant rules were less stringent than the proposed versions. We plotted the survival function of these rules, measured by the probability that a rule would maintain its original level of stringency (Appendix Exhibit 3).12 As the length of time to finalization increased, the probability that the final rule was less stringent than the proposed version increased significantly (p ¼ 0:003).

Discussion We evaluated all recent significant medical product rules proposed by the FDA and found a median time to finalization of 7.3 years, with prerule and postreview deliberation accounting for the majority of that time. Economically significant rules, which involved cost-benefit analyses, were associated with an additional delay of two years. The longer the FDA took to finalize a rule, the less stringent the rule was likely to be. There are several possible explanations for the long duration of rule development. During prerule deliberation, the FDA frequently convenes open meetings and advisory committees and solicits requests for information, all of which contribute to the lag between the statutory requirement for a rule and the publication of a proposed draft. Postreview deliberation, which includes reading and responding to each comment, can also

involve requests for information and can be delayed by court orders and other outside interventions. Some legal scholars have suggested that delays during this phase relate to the sensitivity of agencies such as the FDA to subsequent judicial review. In particular, courts have been more likely to overturn rules in cases where agencies did not adequately explain changes that occurred between the proposed and final versions or did not respond meaningfully to public comments.16 Stakeholder engagement is necessary for writing a balanced rule: Rulemaking involving notice and comments is designed to allow equal opportunity for regulated entities, advocacy groups, and the public to provide agencies with information—for example, on the rule’s feasibility or projected costs. However, the process of involving stakeholders does not fully account for the considerable delays we found in the finalization of several medical product rules. For example, we found no significant difference in total time to finalization or in postreview deliberation between rules with large numbers of comments and rules with fewer comments. Other factors that influence how and when the FDA decides to publish a rule after receiving input from the public and the Executive Office, such as the nature of internal agency decision making, deserve further investigation. The slow pace of FDA rulemaking is a critically February 2014

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FDA Transparency important issue for policy makers to address. Extended delays can lead to inefficiencies by increasing uncertainty about how and when entities affected by a rule will need to change their operations. Similarly, when rulemaking seeks to address a pressing public health concern, as was the case with the 2004 rule banning ephedrine dietary supplements, unnecessary delays contribute to preventable morbidity and mortality. Congress has used its own ad hoc method— statutory deadlines—to speed up the regulatory process. By signaling urgency and legislative intent, statutory deadlines for rule completion can diffuse opposition and incentivize compromise.17 The FDA and other agencies often respond to deadlines by issuing interim final rules, which are essentially final rules that provide for public comment after publication rather than before. Some scholars have suggested that the FDA has also increasingly relied on nonbinding guidance documents to avoid the rulemaking process altogether.18 However, both interim final rules and guidance documents lack the meaningful public comment that is characteristic of rulemaking, which may lead to lower rule quality. To achieve sustainable improvements in rulemaking efficiency, Congress should consider proposals to increase regulatory staffing at FDA. Dedicating more resources to the rulemaking process would benefit all parties. For example, industry would have greater certainty and regulatory clarity to use in making business decisions and allocating capital. The public would benefit from more expedient issuance of rules that would protect the public health and reduce the risks of harms from medical products. Our findings also highlight the need for transparency in the “black box” of the rulemaking process.We found that the stages that contribute most to rules’ time to finalization—time spent by the FDA—are also the least transparent. For example, OIRA is required to publish records of the meetings it holds with outside parties. By contrast, the FDA is not, despite literature indicating that the pre-rule period is a time when the entities to be regulated by a rule lobby the agency.10 The FDA could report a summary of progress for each rule under development and reasons for delays on its website or as part of the annual regulatory agendas published across the federal government. A similar approach was taken by the Environmental Protection Agency, with the creation of its public Regulatory Development and Retrospective Review Tracker website,19 after public outcry over “missing” rules during the George W. Bush administration.20 This minimal amount of disclosure would make the FDA more accountable and responsive to stakeholders while allowing the agency to retain a measure 314

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The relationship between rule stringency and other metrics of quality, such as health outcomes, is unclear.

of discretion and flexibility. Our data collection process identified other critical deficiencies in regulatory transparency. Although Executive Order 12866 requires agencies and OIRA to identify and make available to the public a summary of the substantive changes to a rule resulting from OIRA review, the availability of this information is limited. For example, before 2010 the FDA provided documents with “tracked changes” for several rules, which made it possible to distinguish between edits made by the FDA and those suggested by OIRA reviewers. In recent years, that distinction has not been maintained. The FDA and OIRA should improve the electronic availability of these documents with “tracked changes” and of public comments submitted in response to rules. In addition, Executive Order 12866 requires that agencies identify changes made by OIRA within the rule itself in “plain, understandable language.” Unlike public comments, which the FDA meticulously summarizes and responds to, changes suggested by OIRA reviewers were not mentioned in any of the rules that we analyzed. This absence is important because our data suggest that OIRA changes can be meaningful. We found that OIRA review led to reductions in rule stringency in more than one-third of the economically significant rules, and it did not lead to an increase in stringency in any of the rules in our sample. A summary of changes to a rule resulting from OIRA review would allow the public to better understand how and why the rule changed over time. This information could be implemented with an online “track changes” tool, such as the one developed by OpenCongress .org for legislation,21 along with in-text summaries of changes suggested by OIRA. Finally, empirical literature on rulemaking at the FDA remains underdeveloped, and further research is needed to better understand the determinants of rule quality and the accuracy of cost-benefit estimates. For example, the relation-

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ship between rule stringency and other metrics of quality, such as health outcomes, is unclear. In the two cases we analyzed in which types of commentators disagreed strongly about whether the rule should become more or less stringent (rules 0910-A494 and 0910-AF15; see Exhibit 3), the final rule was less stringent. A retrospective analysis of rules and their actual effects could help resolve these uncertainties.

Conclusion This study provides quantitative insights into the FDA’s regulatory process and the evolution of its proposed rules. The process of public comment This article was based on work undertaken by Thomas Hwang as part of a research seminar at Harvard University led by Aaron Kesselheim. Hwang was an intern at the Office of Information and Regulatory Affairs (OIRA) in the Executive Office of the President in the spring of 2012, but OIRA had no role in the study design,

and, in some cases, executive review is meant to ensure that agencies such as the FDA publish thoughtful and well-reasoned rules and analyses that consider the rules’ estimated burdens and benefits. However, the current system is also associated with delays in the issuance of significant medical product rules. These delays are primarily the result of internal agency deliberation, which we found predicted the likelihood that the final rule would be less stringent than its previous version. Policy makers should make the rulemaking process more transparent and should consider dedicating more resources to improving the efficiency of regulatory activities. ▪

data collection and analysis, decision to publish, or preparation of the manuscript. This study was based solely on publicly available documents and databases, and the opinions expressed in the article do not reflect those of OIRA in any way. Aaron Kesselheim’s work is supported by a career development award from the Agency for

Healthcare Research and Quality (Grant No. K08HS18465-01), a Greenwall Faculty Scholarship in Bioethics, and a Robert Wood Johnson Foundation Investigator Award in Health Policy Research. The authors thank Konstantin Kashin for insightful early conversations on their statistical approach.

10 Yackee SW. Sweet-talking the fourth branch: the influence of interest group comments on federal agency rulemaking. J Public Adm Res Theory. 2006;16(1):103–24. 11 The divisions at the FDA that issue medical product rules are the Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Center for Devices and Radiological Health; Office of Policy, Planning, and Legislation; and Center for Food Safety and Applied Nutrition. Additional details are provided in Appendix Exhibit 1; see Note 12. 12 To access the Appendix, click on the Appendix link in the box to the right of the article online. 13 Wagner W, Barnes K, Peters L. Rulemaking in the shade: an empirical study of EPA’s air toxic emission standards. Adm Law Rev. 2011;63:99–173. 14 Carpenter D. Reputation and power: organizational image and pharmaceutical regulation at the FDA. Princeton (NJ): Princeton University Press; 2010. 15 Food and Drug Administration. OMB comments on the proposed rule: current good manufacturing practice in manufacturing, packaging, or holding dietary ingredients and dietary supplements (Docket

No. 96N-0417) [Internet]. Silver Spring (MD): FDA; 2003 Mar 13 [cited 2013 Jan 13]. Available from: http://www.regulations.gov/ #!docketDetail;D=FDA-1996-N-0028 Funk WF, Shapiro SA, Weaver RL. Administrative procedure and practice: problems and cases. St. Paul (MN): West Publishing Company; 1997. Lavertu S, Yackee SW. Regulatory delay and rulemaking deadlines. J Public Adm Res Theory. 2014; 24(1):185–207. Lewis KM. Informal guidance and the FDA. Food Drug Law J. 2011; 66(4):507–50. Environmental Protection Agency. Regulatory Development and Retrospective Review Tracker [home page on the Internet]. Washington (DC): EPA; [last updated 2014 Jan 2; cited 2014 Jan 2]. Available from: http:// www.epa.gov/regdarrt Heinzerling L. Inside EPA: a former insider’s reflections on the relationship between the Obama EPA and the Obama White House. Pace Environmental Law Rev. Forthcoming. Sunlight Foundation. OpenCongress [home page on the Internet]. Washington (DC): Sunlight Foundation; [cited 2014 Jan 2]. Available from: http://www.opencongress.org

NOTES 1 Hamburg MA, Sharfstein JM. The FDA as a public health agency. N Engl J Med. 2009;360(24):2493–5. 2 Kerwin CM. Rulemaking: how government agencies write law and make policy. 3rd ed. Washington (DC): CQ Press; 2003. 3 Kagan E. Presidential administration. Harv Law Rev. 2001;114: 2246–385. 4 Sunstein C. The Office of Information and Regulatory Affairs: myths and realities. Harv Law Rev. 2013; 126:1838–78. 5 Wood SF. Women’s health and the FDA. N Engl J Med. 2005;353(16): 1650–1. 6 Avorn J, Shrank W. Highlights and a hidden hazard—the FDA’s new labeling regulations. N Engl J Med. 2006;354(23):2409–11. 7 Memorandum and order, Tummino v. Hamburg, 4 Apr 2013 (US District Court, Eastern District New York, No. 12-CV-763). 8 Office of Information and Regulatory Affairs. Reginfo.gov [home page on the Internet]. Washington (DC): OIRA; [cited 2014 Jan 2]. Available from: http://www.reginfo.gov/ 9 Regulations.gov [homepage on the Internet]. Washington (DC): Regulations.gov; [cited 2014 Jan 2]. Available from: http://www .regulations.gov

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Quantifying The Food And Drug Administration's rulemaking delays highlights the need for transparency.

The Food and Drug Administration (FDA) frequently uses its rulemaking process to establish or modify the way it regulates drugs, medical devices, and ...
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