Posted by Seth Whitelaw, Director, Deloitte & Touche LLP
Just before the July 4,2014, the U.S. Food and Drug Administration (FDA) released a draft of its strategic priorities for the next four years. In case you were busy celebrating the holiday and didn’t have a chance to read through all forty pages of the report, here is a quick recap of some of the goals the FDA will be focusing on between now and 2018. The FDA’s updated goals align closely with the trends we highlighted in our recent mid-year overview of the regulatory environment in life sciences, which looks at these issues in more detail.
Goal #1: Enhance oversight of FDA-regulated products by (1) increasing use of regulatory science to inform standards development, analysis and decision-making; (2) reducing risk in manufacturing, production and distribution; (3) strengthening detection and surveillance of product problems and (4) improving response to identified and emerging problems.
As noted in our mid-year overview, patient safety continues to be a top priority on the health policy agenda and is garnering renewed interest from the FDA and other regulators striving to improve health outcomes by improving care processes and ensuring quality of care.
Counterfeit medicines are a good example of the many challenges the FDA is targeting to help safeguard patients. The continued rise in prescribed and non-prescribed counterfeit medicines entering the legitimate supply chain is prompting higher levels of vigilance across the life sciences industry. Track and trace solutions can help protect the integrity and authenticity of drugs throughout the supply chain and provide a foundation for improved patient safety by giving manufacturers, distributors and pharmacies a systematic method to detect and control supply chain security risks: counterfeiting, drug diversions and improper handling . Deploying track and trace solutions can also enhance the top and bottom line by boosting efficiency in the supply chain and distribution channel, improving compliance and reducing the frequency of theft and counterfeiting.
Goal #2: Improve and safeguard access to FDA-regulated products to benefit health by (1) increasing regulatory science capacity to effectively evaluate products; (2) improving the effectiveness of the product development process and (3) improving predictability, consistency, transparency and efficiency of the review process.
The FDA and other regulatory agencies around the world are streamlining and accelerating their approval processes for drugs that appear to offer benefits over available therapies for serious or life-threatening diseases. To qualify for accelerated approval, a drug must demonstrate superior efficacy, tolerability and consistency. Some drugs might have efficacy comparable to an approved drug but utilize a different delivery mechanism, raising questions about consistency. This can be a major barrier to accelerated approval.
In an effort to bring new products to market earlier, the FDA has recently shown an increased desire to collaborate with businesses to accelerate the approval process and increase drug development efficiency. Collaborating with the agency during the initial stages of drug development can help a company better align its clinical development programs with the FDA’s current thinking and standards. However, collaboration also presents a number of risks — including questions about who owns the rights to intellectual property that is jointly developed. To avoid problems, companies will likely need a well-developed strategy to identify and effectively manage collaboration risks.
Goal #3: Promote better informed decisions about the use of FDA-regulated products by (1) strengthening social and behavioral science to help patients, consumers and professionals make informed decisions; (2) improving patient and provider access to benefit-risk information and (3) improving safety and health information provided to the public.
The FDA and patient advocacy groups are actively pushing for greater transparency in the relationships between life sciences companies and health care providers. While some might argue that the Physician Payment Sunshine Act is already changing the landscape — as demonstrated by the decline in payments to health professionals for promotional speeches — the impacts thus far only highlight the need for life sciences and health care companies to maintain rigorous compliance programs to minimize the potential of engaging in unethical or illegal practices. Compliance programs should closely examine physician relationships and the incentives that drive them, which will require transparent information sharing along with a full understanding of the associated risks.
In recent years, there has been increased interest by large pharmaceutical companies in using technologies such as social media and analytics to monitor their products and improve transparency. Key stakeholders in the industry — including patients, healthcare providers and insurance companies — interact using social media on a daily basis. As a result, there is a wealth of data on the internet that pertains to a company’s product safety, effectiveness and reputation. Of course, new technologies can introduce unintended consequences and risks in areas such as patient safety, privacy and security, creating the need for pro-active oversight and regulation.
What does this most recent draft from the FDA mean for life sciences companies? Simply put, it provides a clear roadmap for improving systems and processes to get ahead of the new regulatory requirements. Although the overall timeframe for these strategic priorities is from 2014 to 2018, the impact in many areas will likely be felt sooner rather than later. Now is the time to set the wheels of change in motion.