Regulation of economic activity is ubiquitous around the world; laws are enacted with altruistic goals of preventing harm to consumers or of ensuring that private companies participating in society behave ethically and legally while having a primary objective of earning profits for their stakeholders.  The appropriateness and extent of regulatory oversight and enforcement, and whether or not it achieves its desired effects, is a topic of considerable debate; however, the certainty of some level of oversight and enforcement of the laws that are the source of the regulations is a given.

Because laws are often written to address complex and sometimes rapidly changing environments, lawmakers place broad discretion into the statutes, which will then be interpreted and enforced administratively through published regulatory rules. The pace of development of new rules, changes to existing rules, and the application of enforcement of these rules can be dynamic, reflecting political philosophies and the balance of power within the government at any given time. As long as the rules are interpreted to be consistent with the underlying legislative statutes, these changing regulations carry with them the force of law, which in turn has significant potential impact on business as well as society.

Regulations applied by federal agencies do, in fact, change over time to respond to changes in technology, problems, or business practices that conflict with the rules, or even with the laws themselves.  The size of the Code of Federal Regulations (CFR), where final rules are published to become effective as regulations, spanned over 145,000 pages in 2008.  According to a 2010 study led by George Washington University, the federal government budgeted a record $59B to fund regulatory enforcement by all federal agencies, which was carried out by nearly 250,000 employees.  A 2010 Small Business Administration study estimated the cost of regulation to the US economy at approximately $1.75 trillion dollars.

Dan McGinn, Senior Editor of Harvard Business Review, has described the important influence of government regulation to business in the context of Michael Porter’s seminal work, “The Five Competitive Forces That Shape Strategy.”  McGinn questions whether government policy should be elevated from a mere “factor” to join the original five critical forces in Porter’s work (threat of entry of new competitors, intensity of competitive rivalry, threat of substitute products, bargaining power of customers, and bargaining power of suppliers).  While government policy may ultimately rise to that level, McGinn points out that, based how much senior executives time and resources is invested in influencing government policy, it is already an oversized factor in developing business and product strategies.

The Food and Drug Administration is one of the largest, most visible, and influential federal agencies in the United States Government.  FDA regulates nearly $1 trillion worth of consumer products, or 25% of annual consumer expenditures in the US, from food, cosmetics, and tobacco to drugs and medical devices.  Indeed, the Agency’s role goes beyond domestic boundaries, as it regulates nearly a third of all imports entering the United States.   With more than 9,000 employees in offices in all 50 states, FDA is a familiar face of government to consumers, and one which has traditionally enjoyed a positive and trusted relationship with the public.

The Anson Group was formed with the mission of helping its Clients deal successfully and profitably with the unique challenges of medical technology regulation. This means doing more than simply following the required processes and protocols for submitting regulatory forms, or quoting sections from the CFR; it means helping our Clients tangibly extract more value from their unique technology innovations, while maintaining compliance with the complex body of rules that govern their use to treat or diagnose patient conditions.

There are three major ways that Anson Group delivers enhanced value to our clients who wish to sell their technology based products for regulated use:

1. Commercialization Support
   Food and Drug law requires that many products obtain pre-market approval or clearance from the FDA before they can be legally sold to customers in the United States.  While similar laws exist worldwide for these products, in some cases, even the US does not require such approval.

   Anson has helped many Clients successfully fulfill requirements necessary to obtain pre-market clearance or approval for their regulated medical products, with services ranging from pre-clinical data and clinical protocol study development through the regulatory filings and submissions.

2. Regulatory Compliance
   Many companies, especially new entrants to markets regulated by FDA, focus their attention almost exclusively on commercialization and obtaining approval to market and sell their product legally.  This common misconception of the complete breadth of FDA regulatory oversight can create serious problems for manufacturers who do not develop the appropriate processes and controls across their operation required by FDA, from product design and quality system controls to post-market complaint handling and corrective actions.  In extreme cases for companies that ignore compliance issues, FDA can impose fines, sales injunction, product seizures, and personal legal liability on executives of the company.  Even less serious problems can carry significant financial and time risks that can be avoided or mitigated through proper planning.
3. Navigating the Changing Landscape of Networked, Connected Healthcare
   Digitization of healthcare will have broad and significant impact on all participants in the healthcare ecosystem.  Consumers will play a more active role in “P4” medicine (Predictive, Personalized, Preemptive, and Participatory), which can only fully be realized by using interconnected, digitized healthcare applications and networks.  Payers, providers, drug companies, medical device companies, and the government will all rely on interoperable and interconnected electronic healthcare systems to coordinate care and move to more effective, efficient, and higher quality services.  The digitized healthcare system will move society away from a system of transaction-based, fee-for-service acute patient care encounters to one of continuous monitoring, treatment, and proactive patient wellness management performed outside the four walls of traditional care facilities.

   New entrants to the healthcare system will be connected to the “Healthcare Internet” or will provide the enabling technology which makes that connectivity possible.  Retailers, banks, consumer electronics companies, IT companies, and telecommunications suppliers will all play a more active and involved role in the future of networked healthcare.  In the meantime, government policy makers and regulators will struggle to keep pace with the rapid development of technology and, in some cases, unintended “side effects” of technology deployment that raise questions of risk to patients that must be mitigated.

   The Anson Group is a thought leader in the identification of issues the light of regulatory clarity and in development of methods and approaches for our Clients to obtain and maintain regulatory compliance in the Network Age.  Our strategic partnership with EpsteinBeckerGreen, the nation’s leading and largest healthcare law firm, provides Anson with the ability to engage multi-disciplinary expert teams that include legal experts in the areas of food and drug law, security and privacy, reimbursement, anti-trust, and fraud and abuse, areas that may need consideration of both legal and regulatory expertise for Client innovations containing potential risk elements.  Anson works to both track and chart the future of digital networked healthcare with many of the world’s leading Connected Health organizations, such as the Continua Alliance, West Wireless Health Institute, Center for Connected Health, and mHealth Initiative, and is a co-founder, with EpsteinBeckerGreen, of the mHealth Regulatory Coalition, an organization of technology companies, healthcare providers, and non-profit patient/provider advocates developing a guidance document to describe the aspects and classification of FDA regulation for mHealth.