Recently, Philadelphia City Council moved a proposed ordinance (Bill number 180888) out of committee that would require pharmaceutical representatives to register with the Health Department whenever they are engaged in selling, marketing or promoting medications on behalf of their companies.
At PCMS, we are very concerned regarding the proposed ordinance’s unknown and unintended long-term consequences that might hinder patient access to vital medications and innovations in treatment. We understand the ordinance was proposed to address the ongoing opioid painkiller crisis by limiting the access or influence a sales representative has over a physician. While we applaud any intent toward ending the opioid epidemic, this ordinance raises many more questions than it answers.
As written, the ordinance (Bill number 180888) would require pharmaceutical representatives to register with the Health Department and display an ID badge whenever they are engaged in selling, marketing or promoting medications on behalf of their companies who operate in the city and additionally submit any product marketing materials to the city for review.
How will this process work? How will this be managed? The volume would be enormous. The turnaround time for the Department to complete the reviews would be significant. To our organization’s knowledge, no other states require a “pre-approval of written materials.”
At a professional level, the ordinance is disrespectful to physicians. It presumes you lack the judgment, moral values and ethical code to make decisions based on medical science and in the best interest of their patients. The unintended consequences of the proposed ordinance could dramatically outweigh any benefits supposedly designed to address the very real opioid addiction challenges our city and country face.
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 FDA. The added level of local scrutiny in the ordinance is unnecessary and a waste of taxpayer funds.
Also as part of the Physician Payments Sunshine Act (PPSA), the Centers for Medicare and Medicaid Services (CMS) implemented The Open Payments Program (OPP) to create transparency regarding the financial relationships between physicians and the biomedical industry. Manufacturers of drugs, medical devices and supplies since 2013 have been mandated to submit their payment records and other “transfers of value” made to physicians and teaching hospitals to CMS.
As constructed, the ordinance could place an unnecessary restriction on professional workers and perhaps limit access to medications patients need. There’s no place within the limits of the First Amendment for officials to decide who can get permission to talk to physicians about legal pharmaceutical products – it should be up to the physicians to choose who they listen to for treatment advice.
We urge you to please contact City council members today with these important concerns about this ordinance (Bill number 180888) as currently written.
Please let us know if you have any questions?
Mark C. Austerberry
Philadelphia County Medical Society
2100 Spring Garden Street
Philadelphia, PA 19130
Phone: 215- 563-5343 x101
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