Whenever a private enterprise has business dealings with a state or federal government or is regulated by them, the records submitted are considered to be a part of the public domain. This doesn’t imply that every record is for public viewing. However, it means that these records can be considered public unless exempted by the federal or state law that can permit the records to be withheld by an agency.
Before submitting the records, the companies should understand the different components of law and ensure that the confidentiality of the legitimate material is not compromised. Exemptions related to confidential, proprietary, or trade secret information are one of the most fundamental defenses for the corporate world.
This is true for the biotech and the pharma companies as well. The C-level management in these companies needs to understand the importance of sunshine laws and become aware of them.
Under the Freedom of Information Act (FOIA) 1967, anyone can raise a Freedom of Information Act (FOIA) request to access the records of these privately held companies. There have been instances where the companies were not even given prior intimation by the government that someone was seeking their records. Therefore, it is very important to understand that which records are public under the law and how to protect the records. For that to happen, the company needs to segregate the public and non-public information. If this isn’t done at the right time, then the concerned pharma or biotech company would struggle to protect the records prior to their release owing to the deadline pressure, which can include costly litigation options as well.
The common perception that transparency laws apply only to the citizens or the media is a myth. In reality, the C-level management of biotech or pharma companies should identify sunshine laws as an important business tool. Any document submitted can be easily accessed by raising an FOIA request. The law is like a double-edged sword and understanding it, is crucial for the corporate world.