Perspective: Pharmaceutical industry in need of regulatory reform

With the recent government shutdown still fresh in our memories, our elected officials should forge a consensus on the most pressing economic concern for businesses, regulations. Working in the pharmaceutical industry has shown me the challenges businesses face in keeping up with the size and scope of increasing regulations, and I wonder whether our regulators understand the real burden of these policies.

Of course, there are good and prudent reasons for regulation and licensing, especially in the pharmaceutical industry. The expertise and good judgment of the local pharmacist is crucial to sustaining a first-rate health care system and protecting the health of our customers. No one I know in the industry would dispute that.

The problems with regulations come when community pharmacies are subject to multiple, overlapping regulatory jurisdictions that are absorbing more and more time and expense. For example, we're dealing with not just the Food and Drug Administration, but a maze of other agencies, like the Drug Enforcement Agency, occupational safety regulators at the state and local levels, and trucking and shipping regulators. All of these regulations come in addition to the massive regulatory expansion that attends the implementation of the Affordable Care Act.

America's community pharmacies generate more than $93 billion in economic output annually and employ more than 240,000 nationwide. Lately, I hear more and more busin ess owners talk about how they simply can't invest, expand or hire because the unpredictability of these regulations make it difficult for industries, to invest in the future.

It's no secret that in the wider businesses sector government intervention in the economy has been increasing dramatically. Currently, there are some 3,500 new federal regulations in the Washington pipeline. And I read that since 2006, there has been a 60 percent increase in "significant" regulations, or those having a direct economic impact of $100 million or more.

Reading these numbers, you get a concrete picture of why small businesses are backing off hiring and investing. Some say they wouldn't even have started a business if they'd known how burdensome the regulatory demands would have become.

One of the quickest, most effective and least costly ways to begin to forge consensus is on regulatory reform. While regulations play an important role in protecting the public and the environment, the current regulatory system has become a drag on economic growth and job creation.

Fortunately, Missouri's U.S. Sen. Claire McCaskill, the Democrat chair of the Subcommittee on Financial and Contracting Oversight, could prove a highly influential role in reform. Her committee has jurisdiction over federal financial management, acquisition, and procurement in Homeland Security and Government Affairs. This position allows Sen. McCaskill to be a catalyst for change, relieving businesses from the unnecessary challenge of inconsistent regulations.

We can work toward a system of openness, where research and data models that underpin decisions are shared with business. Reviews of new regulatory proposals should be conducted by experts, with a thorough cost/benefit analysis. Enforcement actions should be exercised with good judgment, allowing innocent mistakes and paperwork errors to be resolved without inordinate penalties and fines. We cannot afford to make keeping up with regulations a full-time job.

So let's get started. A balanced approach to regulatory change will allow businesses, like our community pharmacies, to get back to basics - creating jobs, spurring growth and serving the public.

Ron Fitzwater is chief executive officer of the Missouri Pharmacy Association.