Licensing and Registration Laws for State Pharmaceutical Representatives

On January 1, 2022, SB 763 came into effect in Oregon, requiring pharmaceutical sales representatives (PSRs) to obtain a license before marketing or promoting pharmaceuticals to healthcare providers. Oregon is not the first jurisdiction to pass such a law, but it is one of the few jurisdictions in the United States to require licensing or registration of ESPs. This article discusses SB 763 and similar laws, regulations, and ordinances in effect in Nevada, Illinois, and Washington, DC below.

Oregon

SB 763 covers ISPs who market or promote pharmaceuticals to health care providers. A “health care provider” is a person or entity authorized, certified or otherwise authorized under the law of Oregon to prescribe, supply or distribute pharmaceutical products. If a PSR visits healthcare providers in the state of Oregon for more than 15 days in a calendar year, the PSR must obtain a license from the Department of Consumer and Business Services (DCBS).

To obtain the license, an applicant must complete a vocational training course specified by the Director of DCBS. The education course may include training in ethics, pharmacology, and pharmaceutical marketing laws and regulations. Critically, the DCBS specifies qualified people to deliver vocational training, and employers cannot provide vocational training. The applicant must also complete an application form, which includes professional and personal contact details, documents demonstrating the completion of vocational training and pay a license fee of $ 750.

Once a PSR is authorized, it must provide DCBS with certain information, including:

  • Documentation demonstrating the completion of vocational training;

  • A list of Oregon healthcare providers that PSR has contacted since DCBS’s last request or during the calendar year;

  • The number of times the ISP contacted each health care provider;

  • Pharmaceuticals promoted;

  • Whether the PSR has provided samples of products, materials or gifts and, if applicable, their monetary value; and

  • Whether the ISP paid the health care provider for their time.

Once DCBS issues the license, the license is valid for the entire calendar year issued and cannot be transferred. In addition, if there are any changes in the information contained in the PSR application or material changes in the business operations of the licensed PSR, the licensee must notify DCBS in writing of such changes. DCBS can specify by rule what constitutes a “material change” in business operations.

Chicago, Illinois

As of July 1, 2017, section 4-6-310 of the Chicago Municipal Code requires that PSRs who market or promote pharmaceuticals to healthcare professionals in Chicago for more than fifteen calendar days per year obtain a licensed from the City of Chicago Business Affairs. and consumer protection. A “health professional” means any physician or health care practitioner who is licensed to provide health services or to prescribe pharmaceutical or biological products. The definition excludes medical science liaison officers, wholesale distributors, and directors or supervisors of pharmaceutical representatives, who do not interact directly with healthcare professionals while in Chicago.

In order to obtain or renew a license, a pharmaceutical representative must undergo professional training, which may include training in ethics, pharmacology, laws and regulations applicable to pharmaceutical marketing and other areas than the commissioner of the public health (CPH) may designate. The CPH will identify and publish the institutions that can offer courses that would meet the continuing education requirements. Like Oregon, an ISP employer cannot provide job training.

Pharmaceutical representatives must provide the following information to the CPH:

  • A list of city of Chicago health professionals contacted;

  • The number of times health professionals were contacted;

  • The place and duration of the contact;

  • Pharmaceuticals promoted;

  • Whether samples of products, materials or gifts of any value have been provided to the healthcare professional and the value of the products, materials or gifts; and

  • If and how the healthcare professional was paid for contact with the pharmaceutical representative.

Nevada

As of October 1, 2017, section 439B.660 of the Revised Statutes of Nevada requires manufacturers of prescription drugs to provide a list of their ISPs to the Nevada Department of Health and Human Services (NV HHS). If a PSR is included in a report to NV HHS, the PSR must submit an annual report to NV HHS. If the PSR is not on the drug manufacturer’s list, the representative is not authorized to market the manufacturer’s drugs to any healthcare provider, pharmacy or its employees, or operators. or employees of a medical establishment. PSR also cannot market the drugs for sale to residents of Nevada.

The NV DHHS Technical Guidelines on Drug Transparency (Guidelines) state that a PSR operates in Nevada if the PSR physically resides or travels to Nevada for five days or more to communicate with healthcare providers. An ISP cannot engage in the marketing of prescription drugs to physicians or other healthcare providers, pharmacists or pharmacy employees and employees of medical facilities without being registered with the NV. HHS. The Guidelines define “marketing” as “providing educational presentations and / or details to inform prescribers of their products in order to influence them to purchase or prescribe them”. The Guidelines also state that a PSR must be registered if they meet with physicians or other healthcare providers to answer questions about the products, such as their use and benefits, or provide information and resources. to key decision makers to encourage them to buy. or prescribe the product.

By March 1 of each year, anyone on a list submitted by a pharmaceutical manufacturer must submit a report to NV HHS that includes:

  • The name and manufacturer of each prescription drug for which the representative has provided a free sample to a licensed, certified, or registered Nevada health care provider, pharmacy or employee, operator, or employee from a medical facility or person licensed or certified in Nevada and the name of the person to whom the free sample was provided; and

  • A list of health care providers, pharmacies and their employees, operators and employees of medical facilities to which the pharmaceutical representative has provided any type of compensation in a value greater than $ 10 or a total compensation of one value greater than $ 100 in total.

Washington DC

As of October 1, 2008, Washington, DC has required pharmaceutical detailers (PDs) to license with the Board of Pharmacy (Board). DC Code of Municipal Regulations 17-83 governs licensing requirements. employees or representatives of a licensed healthcare practitioner in Washington, DC The purpose of the communication should also be the sale, provision of information, or promotion of a pharmaceutical product in any way.

An applicant must also provide the Council with proof of graduation from a higher education institution, pay all required license fees, and provide a notarized statement to the Council that the candidate will meet the requirements for the practice of l pharmaceutical aesthetics, including the code of ethics. The Board will waive the training requirement if the applicant submits an affidavit attesting that they have served as a pharmaceutical retailer for at least 32 hours per week for at least twelve months prior to March 26, 2008, and submits two letters from current or previous supervisors. In addition, a PD seeking to renew their license must demonstrate that they have completed 15 hours of approved continuing education in the two years preceding the expiration of their license. These continuing education programs may cover medical and pharmaceutical terminology, FDA laws and regulations, pharmacology, professional ethics, and pharmacology, among other topics.

The license expires at midnight on the last day of February during even years. The Board may request information from PDs regarding their communications with licensed healthcare professionals or their employees or representatives located in Washington DC. In view of this, a PD must retain documents and information related to its communications with these periods for a period of five years from the date of the communication or contact. This documentation should include, but not be limited to:

  • The name, business address and telephone number of the health professional;

  • The date, time and place of the visit;

  • The products discussed;

  • If samples have been provided; and

  • The type of material provided to the healthcare professional, if applicable.

The license remains in effect until the last day of February for even years. If a PD leaves the employment of a pharmaceutical company, he must provide written notification to the Pharmacy Board within ten days. This notification must also include the contact details of a person in the former PD company from whom the Board can obtain the aforementioned documentation.

Conclusion

It is essential that ISPs, PDs and drug manufacturers in these jurisdictions are aware of the registration or registration licensing requirements. Working as a PSR or PD without the proper license or failing to comply with the above requirements may result in civil penalties, suspension or even revocation of the license. Lawmakers and lawmakers must consider the future of each law given the increase in virtual marketing and promotional activity brought on by the COVID-19 pandemic. Each imposes licensing requirements when the ISP or PD spends some time in the state or when interactions with healthcare providers take place in person. Will an PSR or PD need a license if it engages in marketing or promotional activities with vendors in a state, but the PSR or PD is not itself? located in this state? What if the provider and the PSR are in the same state, but their conversations are not taking place in person? Lawmakers and regulators – whether in jurisdictions that have adopted such requirements or in states considering such requirements – must consider whether those requirements should also encompass virtual marketing and promotion interactions.

© 1994-2022 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, PC All rights reserved.National Law Review, Volume XII, Number 6

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