With the spotlight on pharmaceutical pricing and the upcoming presidential election in the U.S., there is ample opportunity for a bit of a shakeup in the regulatory landscape.
In July of 2015, the 21st Century Cures Act was passed by the House of Representatives (344-77). The stated goal of this 360-page bill was to speed up/stimulate the development of new cures for a range of diseases. (Think: precision medicines.) For good or ill, this bill could potentially affect how researchers go about testing medicines—namely speeding a drug to market primarily through testing less patients.
According to an article published in The Washington Post:
“But the 21st Century Cures Act is based on the assumption that there will be more cures if drugs and devices are studied more quickly by testing them on fewer patients—in some cases, on just a handful. Unfortunately, such studies would be too small to allow safety and effectiveness findings to be broken down for subgroups such as men, women, young adults and seniors.
This embrace of smaller, more preliminary studies could drastically lower scientific standards. When fewer people are studied, it is more likely that a drug will seem safe and effective even if it has dangerous side effects for many patients—who may not have been included in those small studies.”
However, there are still countless diseases we have yet to produce cures (or even treatments) for—some of the diseases that may come to mind are the Zika virus and Ebola—which puts regulators in a tough spot. In addition, with frequency of drug shortages and recalls, there is even more pressure on the pharmaceutical industry to increase their output and find a solution.
“In the changing regulatory landscape, it’s more important than ever for pharmaceutical companies to be prepared for the eventuality of a recall. As we have seen over the years, it’s not a matter of if a recalls hits, it’s a matter of when,” said Kevin Pollack, Vice President of Stericycle ExpertSOLUTIONS.
Pollack participated in an exclusive Q&A on the changing regulatory landscape.
Q: Could you describe some of the history behind the makings of the 21st Century Cures Act? What were some of the reasons this particular regulation was put into effect?
Pollack: The 21st Century Cures Act is described by Congress as an initiative to bring America’s healthcare innovation infrastructure into the 21st century. Legislators observed that recent decades saw constant research breakthroughs that are changing the face of disease treatment, management, and cures. Lawmakers also acknowledged that while research is moving quickly, the federal system of drug and device approval hasn’t kept pace. In July 2015, the House of Representatives passed the 21st Century Cures Act, which would incentivize drug manufacturers to develop new treatments for unmet medical needs, accelerate the approval process for drugs designed to treat serious or life-threatening conditions, and expand access to breakthrough therapies.
Q: How will the 21st Century Cures Act affect professionals in the pharmaceutical field?
Pollack: The purpose of the act is to expedite research and development on debilitating diseases and make it easier to get vital treatments to patients who need them. These goals directly affect professionals in the pharmaceutical field in a number of ways. The number of drugs that will be developed and put through trials will change and supply chains will be affected. Changes to an already complex global supply chain also mean the potential for a recall has never been greater. Drug manufacturers must be prepared for this by continually updating and testing recall plans.
Q: With the changing regulatory landscape, how can pharmaceutical companies be best prepared for the eventuality of a recall?
Pollack: Navigating the global pharmaceutical environment has become increasingly complex and as a result, recall preparedness has never been more important for manufacturers. Planning and testing can be the difference between an effective recall and one that negatively impacts brand reputation and revenue. Below are key actions which can help a brand handle a recall:
- Develop a recall plan that includes a dedicated team. An effective recall plan should clearly define the roles and responsibilities of the recall management team in order to quickly and efficiently locate the affected product, remove it from the marketplace, and protect the public.
- Have copies of recall plans from your partners, suppliers, and vendors. Ensuring your own organization has a detailed recall plan is just the first step. Companies throughout the supply chain should conduct drills regularly to evaluate recall capacity and procedures. In today’s global market, it is more important than ever for pharmaceutical companies to know and trust their business partners.
- Test your recall plan. Once a plan is established, manufacturers should conduct periodic recall readiness assessments, or “mock recalls.” This helps individual stakeholders and departments prepare and enables organizations to make necessary updates and improvements to their recall plans.
Q: What do you foresee to be the FDA’s involvement in the 2016 regulatory landscape?
Pollack: The FDA approved 45 new medications in 2015—more than double the number approved just 10 years ago. This marked the first time the FDA gave its stamp of approval to so many new drugs in a calendar year. The 21st Century Cures Act could lead to a high number of FDA approvals in 2016 as well, which would make this the start of a trend rather than a statistical outlier. The FDA is also working with pharmaceutical industry partners to improve quality control through technological advancements. Companies that participate will help write and test the regulations that will soon govern manufacturing processes. These partners will have the opportunity to work closely with the FDA, shape new rules, and preemptively implement systems that may reduce the number of recalls in the future.
Q: In the coming year, how do you see the overall regulation of pharmaceuticals?
Pollack: The Q4 2015 Stericycle Recall Index highlighted the complexities surrounding the pharmaceutical industry, especially as it pertains to counterfeit drugs, mergers and acquisitions (M&A), and regulatory changes. M&A deals reached a new record in 2015, totaling $687 billion in the U.S. alone. From a regulatory perspective, the industry will be keeping a close eye on the 21st Century Cures Act. The proposed legislation was approved by the House and is pending in the Senate. As the leglsiation continues to go through Congressional approval cycles, the burden from regulations will continue to evolve as orgainziations learn to comply and adhere to the new rules.
Q: What are your recommendations for pharmaceutical manufacturers and other professionals in the pharmaceutical field to prepare to be in compliance with regulations in the coming year?
Pollack: 2015 saw significant changes in the pharmaceutical industry. The added complexity means new challenges in recall execution and a greater emphasis on recall preparedness. Companies must document all products and processes, be able to identify and trace products, and stay in tune with manufacturers, suppliers, and distributors. Careful planning and smart strategies will help pharmaceutical companies remain compliant, manage new complexities, and keep customers safe while also protecting their brands.