The Fourth Amendment to the U.S. Constitution states that “The right of the people to be secure in their persons, houses, papers, and effects, against unreasonable searches and seizures, shall not be violated, and no Warrants shall issue, but upon probable cause, supported by Oath or affirmation, and particularly describing the place to be searched, and the persons or things to be seized.” This amendment is an important proscription against the potential overreach of governments or public agencies seeking information from private citizens, businesses, and other organizations. Government agencies attempting to make a legal case against an individual or an organization must adhere to legal restrictions and guidelines in their efforts to obtain information useful in investigations and legal proceedings. The public’s right of access to information is also limited and restricted, with laws such as the Freedom of Information Act (FOIA) proscribing what, when, and how information is to be made public.
Governments have a number of ways in which to gather information. In the context of government oversight and regulation of industries, financial sectors, and other areas of concern, the means by which regulators and government agencies can and does vary according to particular circumstances and situations. At the most basic level, regulators often receive (and transmit) information to and from those that are subject to such regulation. Put simply, “regulators talk to the regulated”(Carter and Harrington, 2000). The information gathered this way is often “communicated in an informal manner and on a voluntary basis,” (Carter and Harrington) and it is this typical form of information-gathering that underpins much of government oversight and regulation.
In instances where the government is attempting to bring a legal case against a business of organization over which it has regulatory power, the need for access to information is of significant concern; acquiring information is what gives regulators the requisite power to successfully prosecute such cases. As an example of how regulatory agencies exert power and gather information in the context of legal proceedings, it will be helpful to examine several specific instances of such activities by a government agency. While the Drug Enforcement Agency (DEA) is responsible at the federal level for the U.S.’ efforts to combat the problems associated with illegal drugs, it is also responsible for regulatory oversight of the handling of legally-prescribed controlled medications. In recent years, the abuse of prescription pain medications and other prescription drugs has received significant attention in the media, and has prompted both greater scrutiny and legal action on the part of the DEA (dea.gov, 2013). When conducting investigations related to the handling and dispensation of medications subject to the Controlled Substances Act (CSA) the DEA must use a number of methods to acquire useful and necessary information.
At its core, the most fundamental question about the government’s interest in acquiring information is whether or not the request is reasonable. Government agencies and representatives who seek information from private citizens or from businesses and other organizations must have a reasonable purpose for asking for such information (Carter and Harrington). If the request for information or access might potentially turn up evidence that a crime or crimes have been committed, it is sometimes necessary to determine if the request for access is reasonable before such access is granted. For example, if the Occupational Safety and Health Administration wishes to carry out an inspection of a business, the OSHA representative typically needs a warrant (Carter and Harrington). If consent for the inspection is granted without a representative of the business requesting a warrant, the information uncovered in the inspection is typically useful and admissible in legal proceedings. If the request to produce a warrant is denied, then the business does not have to grant consent for the search unless and until OSHA is granted a warrant.
In the context of DEA oversight of the handling of legally-prescribed controlled substances, the agency is legally afforded strict control and oversight of the activities of physicians and other prescribers, pharmacists and pharmacies, wholesale and retail distributors of such medications, and the companies that manufacture these medications (dea.gov). A significant body of regulatory procedures, guidelines, and laws has been established that are intended to assure that the activities of these various actors are transparent and that the information related to such activity is easily and readily available to the DEA. Officials from the DEA and the U.S. Department of Justice (DOJ) have used this information to build cases against individuals and organizations that have violated the relevant policies and laws related to the handling of controlled prescription medications; when such information is not forthcoming, these same officials have used the lack of information as the substantive standard for demonstrating a reasonable need for this information (justice.gov, 2013).
In recent years the state of Florida has received intense scrutiny from the DEA for activities within the state that fail to adhere to the guidelines and laws that regulate the handling and dispensation of a number of medications covered by the CSA. According to DEA officials and government prosecutors, Florida has been home to a significant number of so-called “pill mills” (dea.gov); these pill mills are doctor’s offices that prescribe (and sometimes even dispense) pain medications and other controlled substances at rates that the DEA considers to be outside the boundaries of legitimate medical use. These medications are subject to widespread abuse by addicts, and the DEA has charged that the pill mills are contributing to the problem by flooding the streets of Florida with these medications (dea.gov).
Oversight of these medications is supposed to be strict, with doctors limiting the amount of medications they prescribe, pharmacists and pharmacies watching for prescriptions in amounts that should raise red flags, and distributors flagging orders from pharmacies that appear to be excessive. In a recent case that was settled between the DEA and Walgreen’s pharmacy, a large national chain, Walgreen’s agreed to pay a fine of $80 million and to overhaul its methods of handling and dispensing controlled medications (dea.gov). Among the charges that the DEA leveled against Walgreen’s were accusations that the chain and several of its individual pharmacy locations had failed to maintain adequate records and failed to notify the DEA, per statutory regulation, about suspicious prescriptions at the retail level and excessive orders at the distribution level (dea.gov). It is this sort of information that would –or at least should- normally be communicated between the regulated and regulators. When discrepancies in records and errors in reporting were uncovered by the DEA, these failures served as the foundation of the agency’s requests for the warrants needed to uncover more information and ultimately to successfully prosecute their case.
Although the DEA has made the argument that the availability of these controlled medications on the streets poses a significant public health risk, there are a number of factors that make it difficult, or sometimes impossible, for the public to acquire information related to the activities of the DEA both in terms of these investigations and of the overall activities of the agency. The Freedom of Information Act (FOIA), which ostensibly makes it possible for the public to request information about the activities of government, does not always assure that such requests will be met. A number of organizations and individuals who have made FOIA requests to the DEA and DOJ about the activities of the DEA have been denied; according to a recent report, the rate at which such FOIA requests about the DEA have been denied has jumped 114% since the beginning of the administration of President Barack Obama (Rumsey, 2012). Other legal restrictions, such as those that protect the privacy of patients’ medical records, further limit the amount of information available to journalists and other investigators where the DEA is concerned.
There are laws that further protect and enhance the rights of the public to access information about some aspects of the medical and pharmaceutical industries. The Sunshine Act for physicians provides transparency of payments from pharmaceutical companies to physicians, which can expose instances where physicians are receiving payments from the same companies whose medications these doctors are dispensing (healthcaredatasolutions.com). Sunshine Laws offer little in the way of providing access to information about the activities of the DEA, however, despite the fact that the activities of this agency may be as significant an area of public concern as are the activities of the individuals and organizations the DEA regulates. In any instance where information is useful and necessary, whether for use by the government of for the edification of the public, there are a number of laws that are intended to ensure such access.
Carter, L. H., & Harrington, C. B. (2000). Administrative law and politics: Cases and comments. New York, NY: Longman.
DEA.gov / Denver News Releases, 05/30/13. (2013, May 30). Retrieved from http://www.justice.gov/dea/divisions/den/2013/den061213.shtml
Pharma Compliance: License Verification | Healthcare Data Solutions | Healthcare Data Solutions. (2012). Retrieved from http://www.healthcaredatasolutions.com/hdsverify.html
Rumsey, M. (2012, July 17). The News Without Transparency: DEA FOIA rejections have increased 114 percent since the end of Bush administration – Sunlight Foundation Blog. Retrieved from http://sunlightfoundation.com/blog/2012/07/17/the-news-without-transparency-dea-foia-rejections-have-increased-114-percent-since-the-end-of-bush-administration/
Walgreens agrees to pay a record settlement for civil penalties under the Controlled Substances Act. (2013, June 11). Retrieved from http://www.justice.gov/usao/co/news/2013/jun/6-11-13.html