A consumer advocacy group is calling on the FDA to retract draft guidance on patient preference information and end its relationship with a consortium that it maintains is dominated by medical device manufacturers.
In comments on Patient Preference Information — Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Device Labeling, Public Citizen asserts that members of industry have had undue influence in developing a strategy to incorporate PPI in regulatory decision-making.
The group specifically highlights the relationship between the FDA and the Medical Device Innovation Consortium, a public-private partnership that, according to its website, is dedicated to advancing regulatory science.
Public Citizen sees this relationship as too cozy, “resulting in an approach to regulatory development that is centered on industry interests, rather than patient and public health interests.”
The group points out that of the 23 members of the MDIC steering committee, 11 represent the medical device or affiliated industries and seven are FDA officials. Only one member is from a patient group. However even that group is funded by industry.
“This extensive involvement between members of the medical device industry and the officials who regulate them is inappropriate, particularly when presented as an effort to develop a ‘patient-centered’ approach to product development and regulation,” the group asserts. “Device manufacturers and affiliated industries have an inherent conflict of interest: In seeking to incorporate patient views into the regulatory process, these companies are necessarily motivated by the desire to increase the sales of medical devices, and thus their own profits.”
Issued in May, the draft guidance discusses the main factors sponsors and other stakeholders should consider when collecting PPI that may be used in reviewing premarket approval applications, HDE applications and de novo requests.
Submitting this information is optional, but the FDA says it can help when multiple treatment options exist and none is clearly superior, or if patients’ views on a product’s benefits and risks are significantly different from those of healthcare providers ().
Public Citizen doesn’t see the draft guidance as helping patients. If the document is finalized, it will effectively lower the standards of regulatory approval, potentially allowing unsafe, ineffective medical devices on the market, the group says.
To bolster its claims, Public Citizen notes that hypothetical examples used in the draft guidance suggest using PPI when evidence backing the safety and effectiveness of a device is inconclusive.
“Out of all the examples used in the draft guidance, only example C indicates that the FDA might deny approval of the device under consideration, and this denial is made in spite of patient preference information, not because of it,” according to group.
The group also cites a real-world example, EnteroMedics’ Maestro Rechargeable System, as an example of how the FDA’s approach is flawed.
The FDA gave the green light to the device, despite a majority of advisory committee members voting against its effectiveness. The agency cited information from the Center for Devices and Radiological Health’s Patient Preference Weight Loss Study as the basis for its decision, saying patients would accept the risk associated with the implanted device.
Public Citizen says there wasn’t enough transparency of how the agency used the data from the study, adding that the MaxR-MinB calculator tool, which is intended to aid in regulatory decisions related to obesity devices, has not been made public.
“We urge the FDA to include steps for greater transparency in any subsequent version of the guidance, including a pledge to publish individualized results generated by regulatory tools developed using patient preference information, such as the tool developed based on data from the CDRH Patient Preference Weight Loss Devices Study,” the group writes.
A Different View
Most of the other 17 comments were positive and congratulated the FDA for its efforts.
The National Psoriasis Foundation, for example, says it backs the FDA’s commitment to capturing PPI and suggests the agency do more by developing a meaningful definition of patient engagement and establishing a system for gathering patient-reported data.
AdvaMed says the document is informative, but should be less repetitive and more concise.
Further, the trade group disagrees with the FDA’s assertion that patient preference studies considered in a premarket application should generally be described in the labeling.
“Very few preference studies have been done thus far, so it is not clear what impact, if any, including PPI in the labeling would have,” AdvaMed says.
Study data could prove helpful in determining the impact, the group adds, citing MDIC’s ongoing efforts to determine how to effectively communicate the risks and benefits of medical procedures to doctors and patients.