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Trends in Bone Morphogenetic Protein Usage since the U.S. Food and Drug Administration Advisory in 2008: What Happens to Physician Practices When the Food and Drug Administration Issues an Advisory?

ABSTRACT: Study Design Retrospective cross-sectional study of spinal procedures from 2002 to 2010 using the Nationwide Inpatient Sample database. Objective To determine the patterns of bone morphogenetic protein (BMP) usage in fusion surgery before and after the U.S. Food and Drug Administration (FDA) 2008 advisory for the anterior cervical spine to understand how advisories affect U.S. physician practices. Methods Procedures were identified through International Classification of Diseases, Ninth Revision procedure codes and were plotted over time based on fusion procedure type, site, and area of fusion. U.S. national trends were approximated by polynomial regression analysis. Results The majority of the data trends of BMP usage reflect a second-order polynomial model. BMP usage in anterior cervical spine fusion procedures plateaued during the fourth quarter of 2007. The most apparent change in trend was noted in BMP usage pre- and postadvisory in the analysis of anterior cervical spine fusions. BMP percentage of use decreased in this area by 5% from the time of the FDA advisory to the fourth quarter of 2010. Conclusions The decrease in BMP usage in anterior cervical spinal fusion procedures coincided with the timing of the FDA advisory. The fact that BMP continued to be used in cervical spine fusion procedures, even at lower rates, despite the advisory, may reflect the availability of new clinical information that could lessen complications (i.e., lower BMP dose, perioperative steroids, BMP containment). Furthermore, factors like the natural ceiling effect of use or demand for new technology, complications, prohibitive institutional costs, access to information, and insurance compensation may have all contributed to the BMP usage trends observed.

SUBMITTER: Mckie J

PROVIDER: S-EPMC4078162 | biostudies-other | 2014 Jun

REPOSITORIES: biostudies-other

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Project description:Policy Points Food and Drug Administration (FDA) advisory committee recommendations and the agency's final actions exhibit high rates of agreement, with cases of disagreement tending to reflect the proposed action type and degree of advisory committee consensus. In the case of disagreements, the FDA tended to be less likely than its advisory committees to approve new products, approve new supplemental indications, or enact new safety changes. These findings raise important issues regarding the factors that differentially shape decision making by advisory committees and the FDA as an agency, including institutional or reputational concerns.ContextThe Food and Drug Administration (FDA) convenes advisory committees to provide external scientific counsel on potential agency actions and to inform regulatory decision making. The degree to which advisory committees and their respective agency divisions disagree on recommendations has not been well characterized across product and action types.MethodsWe examined public documents from FDA advisory committee meetings and medical product databases for all FDA advisory committee meetings from 2008 through 2015. We classified the 376 voting meetings in that period by medical product, regulatory, and advisory committee meeting characteristics. We used multivariable logistic regression to determine the associations between these characteristics and discordance between the advisory committee's recommendations and the FDA's final actions.FindingsTwenty-two percent of the FDA's final actions were discordant with the advisory committee's recommendations. Of these, 75% resulted in the FDA making more restrictive decisions after favorable committee recommendations, and 25% resulted in the agency making less restrictive decisions after unfavorable committee recommendations. Discordance was associated with lower degrees of advisory committee consensus and was more likely for agency actions focused on medical product safety than for novel approvals or supplemental indications. Statements by public speakers, advisory committee conflicts of interest, and media coverage were not associated with discordance between the committee and the agency.ConclusionsThe FDA disagrees with the recommendation of its advisory committees a minority of the time, and in these cases it tends to be less likely to approve new products or supplemental indications and take safety actions. Deviations from recommendations thus offer an opportunity to understand the factors influencing decisions made by both the agency and its expert advisory groups.

Project description:Introduction: Tobacco control policies have helped to reduce the health, social, and economic burden of commercial tobacco use worldwide. Little is known about the long-term impact of regulatory policies and functioning bodies that make recommendations to inform policies. The Tobacco Products Scientific Advisory Committee (TPSAC) of the U.S. Food and Drug Administration (FDA) was formed in 2009 to evaluate the safety, health, and dependence of tobacco products and provide related advice and recommendations to the FDA and the Secretary of Health and Human Services. This article describes the first 10 years of the TPSAC activities and reflects on the impact of their service on regulatory actions.Methods: We reviewed public documents from the 2010-2019 TPSAC meetings to examine the purposes, TPSAC decisions, public health participation in meetings, and concordance of the TPSAC recommendations with regulatory actions. Meeting agendas, transcripts, public testimony, and presentations were reviewed to obtain this information.Results: Since 2010, the TPSAC held 25 public meetings with 178 speakers who provided oral public testimony. Sixty-four percent of meetings were held from 2010 to 2012, when three congressionally mandated reports were due on the topics of menthol cigarettes, harmful and potentially harmful constituents in tobacco products, and dissolvable tobacco products. Forty-four percent of meetings focused on menthol cigarettes, 32% on modified risk tobacco products, 16% on harmful and potentially harmful constituents, 12% on dissolvable tobacco, and 4% on tobacco addiction/dependence. FDA regulatory actions were largely nonconcordant with voting decisions by TPSAC.Conclusions: The TPSAC has evaluated an enormous amount of science during the first 10 years, but their influence on regulatory policies has been limited. The TPSAC roles and functioning should be reevaluated to determine how TPSAC can better fulfill its mandate to inform the FDA's regulatory decision making, which could ultimately reduce the burden of tobacco use in the United States.

Project description:BackgroundDespite controversy among experts regarding aducanumab's approval by the U.S. Food and Drug Administration, little is known about public opinion on this matter.MethodsWe conducted a representative survey of U.S. adults ages 35 and older to (1) determine opinions regarding aducanumab's approval, (2) identify any evidence of reputational injury to the Food and Drug Administration, and (3) explore opinions regarding policy responses available to policymakers, such as those relating to a national coverage determination by the Centers for Medicare and Medicaid Services. The survey was administered online and in English and Spanish using a probability-based sample derived from the National Opinion Research Center's AmeriSpeak® panel. Selection probabilities in the panel and survey design account for differences in population distribution and expected response rates by demographic. The survey was analyzed using survey weights to adjust for selection probabilities and non-response.ResultsA total of 1025 respondents completed the survey. While approximately three-quarters of respondents were initially unfamiliar with aducanumab, respondents were less supportive of the drug's approval once given information about the drug's potential clinical and economic impact. Sixty-three percent of respondents support restricting aducanumab access to patients most likely to benefit. Seventy-one percent indicated a willingness to enroll a family member with mild Alzheimer's disease in a "waitlist"-style trial to further study aducanumab; sixty percent indicated a willingness to enroll a family member in a randomized placebo-controlled trial. Eighty-one percent agree aducanumab should be withdrawn from the market if confirmatory trials fail. The median respondent was willing to pay $1-5 in higher Part B premiums to cover aducanumab.ConclusionThese findings demonstrate support for a range of proposed policies in response to aducanumab's approval. The opinions of an informed public ought to be considered when developing policies in response to aducanumab's approval.

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Trends in Bone Morphogenetic Protein Usage since the U.S. Food and Drug Administration Advisory in 2008: What Happens to Physician Practices When the Food and Drug Administration Issues an Advisory?

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