Editor: Please tell us about your background and experience.
Mansour: I have been a food and drug lawyer for roughly 20 years, including in the role of in-house counsel at several major food companies. My earlier practice centered largely on international and domestic regulatory work in the U.S., Europe and the Middle East, and my current focus is in the food, drug, cosmetic, medical devices and dietary supplement industries globally. My FDA regulatory practice encompasses the full spectrum of issues, including public policy, litigation and intellectual property.
Editor: What is the status of rulemaking under the FDA Food Safety Modernization Act (FSMA)?
Mansour: There has been progress since FSMA rulemaking began in earnest during the spring of 2011, and the process continues to move along. Currently, a number of open dockets have gone through first-stage rulemaking action, and there is draft guidance available for certain issues, including the FDA’s administrative detention authority, prior notice relative to imported food, efforts to establish foreign FDA offices and the user fee program. The latter is somewhat controversial and refers to the statutory requirement that participating industries fund a portion of the regulatory costs. Some in industry believe the process is too expensive, and the FDA cites user fees as essential to offset insufficient funding.
Editor: Is it helpful to focus on business issues when advising clients on the complex FDA regulations?
Mansour: Everything entails a business element; however, when dealing with regulations that address patient or consumer safety, compliance must always trump business exigencies. Ideally, both work hand-in-hand, but no properly functioning company will subordinate safety concerns to business issues. If a real conflict arises, companies have to face the reality of incurring what are hopefully one-time losses for the sake of compliance and consumer safety – it’s just part of doing business.
One of the perspectives I gained from my in-house experience is the recognition that legal issues don’t exist in a vacuum; they are integral to the business process. Traditional legal memos don’t work in today’s complex environment, in which companies are managing pure business issues – sales, customer relations and international supply chains – while also addressing global competition, public relations and regulatory compliance. In order for companies to make effective decisions about compliance, the law must be understood in the context of the business, and you must be able to help clients make decisions on the fly in what is often a chaotic environment.
There is a natural tension between regulatory authorities and business. A big part of bridging that gap is communicating expectations, understanding both points of view, ensuring that no one feels alienated or disaffected and recognizing that FDA compliance is a cooperative and interdependent process. While the FDA might assert that industry cannot survive without a properly functioning regulatory body, it is equally true that the agency exists in part to facilitate commerce by guaranteeing the safety that both consumers and producers require for a stable stream of commerce.
Once compliance issues are identified, companies recognize the need to comply with the law while minimizing business disruption and regulatory costs. Further, after compliance is achieved, companies expect their legal counsel to help them move on, make the requisite adjustments and get back to business.
Editor: Please talk about the interplay of considerations when advising clients on regulatory matters vis-à-vis R&D.
Mansour: Drug and device products require pre-market approval, whereas food products are largely regulated post-market. At least this system is clear and predictable. Right now, the drug industry is experiencing turmoil with the so-called patent cliff and difficult decisions as to where to focus R&D efforts. There also is the interplay with insurance companies, the U.S. Department of Health and Human Services and the FDA about allocation of R&D resources, both to foster a more streamlined drug approval process and to maximize use of limited funds in getting products to market.
Future R&D is also affected by the fact that drug approvals, device approvals and clearances, as well as combination products, all require more and more time to complete, which frustrates investors and delays groundbreaking research from coming to fruition.
There is a general feeling that the regulatory process has not kept pace with R&D and is, therefore, neither designed nor equipped to deal with a 21st-century industry. Signed into law in 1938, the Federal Food, Drug, and Cosmetic Act was enacted during a different era, and the FDA is struggling to respond to new technologies. The iPhone and iPad, for example, have become de facto diagnostic tools, and, like many newer products, were unheard of just a decade ago. So, there is a real appreciation for FDA’s plight, but also frustration with what many view as a sluggish response time for companies that are ready to market their products.
To address these myriad issues, our practice takes a holistic view that includes complete integration of our health care and FDA groups. This approach is more effective than placing the FDA practice in a silo, as many firms do, because it enables us to address the full scope of issues in a broad context: R&D, regulatory oversight, health care law, insurance, patents and funding.
Editor: In June 2011, the FDA released a special report stating that “the safety of America’s food and medical products remains under serious threat.” What is your reaction to this statement?
Mansour: While this has become a controversial problem – one the FDA is addressing publicly in order to comfort consumers – the safety of food and drug imports is an everyday issue that occasionally flares up and grabs media attention, particularly in the wake of disasters like the 2008 Heparin crisis. In reality, the global supply chain is huge, with many of our drug, dietary supplement and food ingredients being imported from China, India and other countries. Being alarmist about that fact serves no purpose. It ought to be clear to everybody that it has long since been impossible to limit suppliers to U.S. manufacturers. Sometimes, regulators and politicians act as though they awakened that same day to discover this new-found challenge at their doorsteps.
FDA has known this for several years and has established offices in China and in other countries to work with their regulatory counterparts. Though many foreign regulatory structures are not as mature as ours, some contend that the U.S. system also has issues, and we don't always do a perfect job in regulating our own market. In the food safety realm, international organizations, such as the UN’s Codex Alimentarius Commission and its constituent committees, provide assistance to countries in setting standards and developing laws and regulations, and there are numerous international instruments, such as agreements and memoranda of understanding, that are aimed in part at the elusive global regulatory harmonization many seek.
The volume of food, medical and other products moving through the global stream of commerce is staggering, and the overwhelming majority are perfectly safe. The occasional appearance of unsafe products usually arises from the behavior of unscrupulous people who intentionally subvert the system rather than from egregious problems in the system itself. Again, alarmism does more harm than good. Our food and drug products are not under threat; they’re just part of a changing global landscape to which we all are adjusting, and the best solution is to embrace reality, aggressively deal with violations and seek to set standards and procedures based on an international paradigm.
Editor: Are regulatory standards for approving the sale of medical devices typically lower in other countries than in the U.S.?
Mansour: No, and in fact, some believe that Europe does a better job at approving drugs and devices more quickly and with fewer safety issues than the U.S. In fairness, the FDA’s application volume is much higher. Many claim that Europe’s system is successful because it is prioritized and funded properly, while lack of funding remains a major issue for the FDA, hampering efforts to hire appropriate staff and complete approvals in a timely fashion. Overall, I don’t perceive any pattern of one being safer than the other.
Editor: How does the U.S. regulatory regime compare to those in other countries?
Mansour: U.S. regulators have set up offices in China and the EU, which, in turn, intend to do the same here in the U.S. Though cooperative in nature, international gatherings also provide a forum for discussion of differences.
Many in Europe view their food regulatory system as far more robust and less politicized than ours, citing better funding, fewer conflicts of interest, greater focus on product safety and comprehensive consumer information. Of course, there are different opinions, but the point is that the U.S. system is not necessarily seen any longer as the international regulatory gold standard.
The Chinese are still developing their regulatory system and are actively looking for guidance from the EU in particular. The key to constructive change is a growing recognition that global cooperation toward the adoption of best practices is inevitable.
Editor: How are American companies faring internationally in the food and drug industry? Is it true that some countries do not provide adequate protection of intellectual property?
Mansour: They are faring well. U.S. food and drug manufacturers embraced globalization as far back as the 1970s, recognizing its inevitability long before the government did and preparing themselves by establishing sophisticated international supply chain operations. The global operations of these major companies are staffed by nationals who understand their governments and are very good at working through regulatory challenges.
Intellectual property is a complex and decidedly unresolved issue in the global business arena. Many countries have cultural barriers against vigorous patent protection; some simply don’t take it seriously until trade retaliation looms. Improvements are slow and frustrating, but companies have had some success putting pressure on recalcitrant governments.
Editor: Do you have any final thoughts for our readers?
Mansour: The world will become more and more interdependent as we move forward, with 20 to 25 percent of products in the global stream of commerce coming from food, medical devices, drugs and other ingredients. A robust FDA is an integral part of this process; it should be adequately funded and never treated as a nuisance, and enlightened companies will seek a cooperative relationship with regulators to ensure the integrity of their products.
Similarly, governments have much to learn from multinational industries, and it is profoundly shortsighted for anyone to say that industry has no place in the regulatory process. Industry has for years addressed internal self-regulation and product safety as critical business functions and, therefore, can offer an invaluable perspective in a collaborative relationship with regulators. Further, our legal liability system is strict and, thus, offers more than sufficient incentive for companies to address product safety issues before they become a problem.
Finally, we desperately need young scientists to become regulators and to work in R&D, compliance and other critical areas, not only to help business thrive and create more enlightened and intelligent regulation, but also to bring a fresh perspective to the effort to foster global cooperation, both among and between regulators and between regulators and companies. While we have a long way to go, the recognition by business and industry that there is much work to be done is encouraging.