By: Frank Fazio and Rachael E. Garrison
Foreign drug and medical device manufacturers looking to enter the U.S. market often begin operations with a small U.S. based office staffed by a handful of people transplanted from the overseas headquarters. This provides them with a U.S. address for the sales and marketing of products while ensuring that the U.S. personnel understand the corporate culture of the parent and can communicate effectively with overseas counterparts. However, when applying for licensure as a wholesaler or manufacturer, company officers are often posed the question, “Are you a U.S. citizen?” In the case of small foreign subsidiaries, the answer is often “no.” What does it mean to be a United States citizen? United States citizens are individuals born in the United States or individuals granted citizenship status by the Immigration process. United States citizens have proof of citizenship, such as a birth certificate, a social security card, a U.S. passport or a certificate of citizenship.
Whether the life science company is new or previously established, it may encounter many obstacles as a result of the alien status of its employees. Key positions such as designative representatives and corporate officers are often foreign nationals legally present in the U.S., but not necessarily citizens.
The immigration status of corporate officers is increasingly problematic as more states are requiring proof of citizenship for wholesalers and manufacturers. Some states are more stringent than others. Georgia requires the top (5) corporate officers to fill out a Personnel Certification form. This form requires personal information such as name, address, date of birth, social security number, telephone numbers, position held at the firm and questions regarding licensure. In addition, Georgia also requires the applicant to complete the Affidavit of Applicant. This affidavit requires the applicant to answer yes to one of the following statements: 1) “I am a United States citizen 18 years of age or older” or 2) “I am not a United States citizen, but I am a legal permanent resident of the United States 18 years of age or older, or I am a qualified alien or non-immigrant under the Federal Immigration and Nationality Act 18 years of age or older with an alien number issued by the Department of Homeland Security or other federal immigration agency.” Not only does the applicant need to attest to the fact they are a U.S. Citizen or resident alien and allowed to work in the U.S., they need to submit secure and verifiable documentation. The state will accept the following documentation as proof of citizenship: driver’s license, passport, immigration document(s) which includes either your Alien number or your I-94 number and, if needed, SEVIS number. Importantly, Georgia will not accept officers who are legally in the U.S. on a work visa.
Other states such as, Alabama and Hawaii require the applicant to be a U.S. citizen, however, their requirements are less burdensome. In the state of Hawaii, an applicant must be a U.S. citizen or an alien authorized to work. Hawaii requires wholesaler and manufacturer applicants to submit documentation of officer proof of citizenship. Alabama on the other hand simply requires the wholesaler or manufacturer applicants to answer the question, “Are you a U.S. citizen?” If the applicant answers the question, No, then they must submit documentation of legal status in this country.
California does not necessarily have an explicit citizenship requirements, however, all officers are required to disclose their social security number. If the corporate officer does not have a social security number, they will not be allowed to be added to the corporate officer list. This effectively rules out non-citizen officers.
As more states require proof of citizenship, drug and medical device companies may have difficulty securing necessary distribution licenses. This can delay a launch or preclude a market resulting in lost sales. Foreign companies seeking to establish a presence in the United States must consider the citizenship requirements in staffing their U.S. based subsidiaries. Likewise, domestic corporations should consider these requirements when hiring key senior level personnel.