OR WAIT 15 SECS
The role of patient advocates in shaping regulations and policy has put attention on financial and operational links between drug companies and independent health organizations.
The more visible, expanded role of patient advocates in shaping FDA regulatory and policy decisions for drug development has focused attention on the financial and operational links between biopharma companies and independent health organizations. FDA–industry user fee agreements in recent years have promoted “patient centricity” and strategies for giving the “patient voice” a more visible and articulate role in calculating the benefits as well as risks in drug testing and market approval. Patient groups now are more involved in agency deliberations over development strategies for specific drug classes and in vetting approval pathways for new medicines.
Greater patient involvement in regulatory processes, though, has boosted scrutiny of drug company financial support for independent patient organizations, raising questions about whether the views expressed by such groups fully reflect broader public needs and values. During the 2016 debate on the 21st Century Cures legislation, consumer activists criticized “so-called patient advocacy groups” for supporting changes in standards to permit greater consideration of real-world evidence and biomarkers in product approval decisions.
These concerns have been heightened by analyses documenting industry financial support of patient organizations. A study published in the New England Journal of Medicine (NEJM) on March 2, 2017 found that 83% of 104 large patient advocacy organizations receive financial support from drug, medical device, and biotech companies, and that industry executives regularly serve on their governing boards. Similarly, a survey of patient advocacy executives published in the Journal of the American Medical Association (JAMA)in January 2017 reported that 67% of the groups acknowledge industry support [see ]. In 2016, the Project on Government Oversight (POGO) highlighted pharma funding of leading patient organizations such as the National Health Council and the Alliance for Aging Research and the National Organization for Rare Disorders (NORD), raising questions about their independence in backing the Cures legislation and FDA funding by user fees.
The authors of these studies speculate that industry funding raises conflicts of interest, particularly in the area of drug pricing, as patient advocates funded by pharma companies may be less vocal in seeking access to cheaper medicine. In 2016, patient allergy and asthma groups were criticized for failing to speak out against price hikes for Mylan’s EpiPen, as issue raised initially by individual consumers finding the life-saving devices unaffordable. At the same time, a survey of patient groups by PatientView reported a drop in respondents that rate industry as having an “excellent” or “good” reputation, largely due to drug pricing issues. One response, say the analysts, is to require greater transparency in funding sources for patient advocacy groups, as many disclose only ranges of donations, and not detailed amounts by company.
Separately, federal and state investigators are probing pharma company relations with patient advocacy programs related to industry financial assistance to individuals unable to afford certain new, costly drugs. US attorneys have subpoenaed records from several leading manufacturers on whether the funds they provide patient organizations are used to subsidize the purchase of their medicines by Medicare or other government health programs. Consumer advocates maintain that pharma funding of patient co-pays, which is legal for individuals with private insurance or inadequate coverage, is a strategy for manufacturers to steer patients to more costly therapies.
Meanwhile, FDA is looking to improve communications with patients and consumers by forming an Office of Patient Affairs in the Office of the Commissioner. This office would provide a single, central entity to handle inquiries from the patient community and would expand the current patient team in FDA’s Office of Health and Constituent Affairs. One function of the new office would be to help patients understand the agency’s process for obtaining access to unapproved therapies in clinical trials. FDA’s compassionate use program aims to link ill individuals with sponsors developing potentially effective new medicines, but its efforts have been criticized as inadequate by the growing “right-to-try” movement.