The US Food and Drug Administration (FDA) will move forward with a survey of healthcare professionals regarding their opinions and perceptions about prescription drug promotion after receiving approval from the Office of Management and Budget (OMB), the executive branch's regulatory clearing house.
FDA's intent to conduct the survey was first announced in January 2012, when it said in a Federal Register posting that it was soliciting comments on a proposed study entitled "Health Care Professional Survey of Prescription Drug Promotion."
Comments on the proposal were for 60 days, and the proposal was finally sent to OMB for final approved in October 2012.
As Regulatory Focus explained at the time, FDA's study summary explained that consumers and providers alike are subject to direct-to-consumer (DTC) advertising from pharmaceutical companies, and that questions have been raised regarding the influence of these commercials on patient care.
The proposed survey will specifically look at the effects of DTC advertising on so-called "physician extenders"- nurses and physician assistants-that FDA says are providing an "increasingly vital role in primary care delivery." An earlier 2002 study did not include physician extenders, but instead focused on general practitioners and specialists.
"Because DTC advertising likely affects daily interactions between patients and nurse practitioners and physician assistants […] including these groups in the new sample will further understanding of DTC advertising in the healthcare system," FDA explained. The proposed study would also weight the race, age and sex of respondents to better reflect national demographic patterns.
The study is also slated to include a look at how social media is affecting healthcare professionals' prescribing habits, and FDA said its intent was to gain an awareness of "new and merging promotional sites and practices."
Industry Weights in
The proposal received several comments from industry, including from heavyweights Merck and Bausch + Lomb.
Merck said that while it was supportive of FDA's efforts to "gather more evidence on the influence of DTC advertising and prescription drug promotion on interactions between patients and their healthcare providers," it nevertheless had several problems with the study as originally designed.
For example, Merck said the proposed language was unclear as to which specialists would be looked at in the study, and did not define general practitioners. Neither did it specify inclusion criteria in the study, leaving open the prospect that low-prescribing entities could influence the study's outcome.
Merck also said that it hoped FDA would attempt to gather more information about the effects of advertising on prescribing decisions, including how often prescribed products wound up being switched for their generic equivalents at the pharmacy. The company said it favored language that would ask, "On a typical day, for how many of your prescriptions written do you get a call from a pharmacy asking for authorization to switch to another branded product?"
This could change the overall effect of DTC advertising on true prescribing habits, the company said.
Bausch + Lomb's comments, meanwhile, focused on the specific wording of questions to be asked in the study. The company did, however, recommend excluding all seven questions on the effects of social media on prescribing habits, arguing that the questions were "outside the scope of this survey."
Now the question is whether or not FDA adopted any of those recommendations or conceded any of industry's concerns.
FDA's 18 April 2013 Federal Register posting explains only that OMB approved the survey, but does not mention if any changes were made in advance of its submission to OMB. The OMB change control document notes that the survey was approved with changes by OMB's Dominic Mancini, acting deputy administrator of the Office of Information and Regulatory Affairs (OIRA). Those changes, however, were not outlined.
One interesting point of information, however, is the study's cost. FDA will be spending $364,588 to gather the information.
The study expires on 29 February 2016, but FDA said it anticipates concluding the study within 24 months of approval, or by March 2015.