On Nov. 30, the Council of the City of Philadelphia moved a proposed ordinance out of committee that could drastically reduce learning opportunities for physicians and other health-care providers in Philadelphia and require manufacturers to submit any product marketing materials to the city for review, even though the data has been reviewed by the FDA.
A final vote is scheduled for Dec. 13.
Those who introduced and support the ordinance openly state their goal is to help address the ongoing opioid painkiller crisis by limiting the access or influence a salesperson has on a doctor. Of course, the medical community fully supports eliminating opioid abuse. However, the ordinance goes far beyond addressing the opioid crisis.
For those suffering from any illness, this ordinance, given its breadth, could potentially limit access to essential — if not life-saving — medications. Over-regulating all pharmaceutical relationships with physicians can hurt the opportunity for providers to learn about new and important treatments they can offer their patients, including non-opioid pain medications.
From a practical standpoint, the bill is vague and runs the risk of creating additional administrative burdens that offset the positive outcomes it aims to create. The definition of health-care practitioners and health-care providers in the ordinance is broad and could be read to suggest everyone working in the medical profession needs to register with the city.
In addition, the ordinance does not specify what medical authority will review the material submitted, nor does it estimate the costs of such an ongoing review of extensive literature. Pharmaceutical manufacturing is already one of the most heavily regulated industries in the country. Alleged deceptive marketing or sales practices from a small minority of rogue elements in the profession fall under the watchful eye of the FDA. The taxpayer funds spent by Philadelphia for this added level of scrutiny and administrative burden is unnecessary and could be costly.
There are better options the city of Philadelphia can provide to help patients, rather than these broad regulations. First, the Commonwealth of Pennsylvania is already working aggressively on the problem of opioids and informing people about existing programs, such as the prevention campaign at www.pastop.org. Second, resources can be allocated to help patients receive more comprehensive services to support non-opioid pain control methods. Lastly, resources can be allocated to help physicians learn about non-opioid medications that can also provide pain relief.
Bottom line: While there are good intentions behind the ordinance, the unintended consequences are significant. Adding more red tape to the entire medical community for all treatments, particularly non-opioid treatments, is neither efficient nor necessary to continue to address the very real opioid addiction challenges our city, county, and country face.
I’m asking all area patients and providers to contact Council members with important concerns about this ordinance (bill number 180888) as currently written.
Brad C. Klein, MD, MBA is a clinical neurologist and chief operating officer at Abington Neurological Associates, Ltd.