FDA Unveils Database of Drug Side Effects, Procedural Changes

It could be argued that the pharmaceutical and medical products industry—with its high-value, high-regulation product lines—could have the most at stake for achieving operational excellence. Regulatory requirements have risen for this industry struggling to hold down cost.

Today, the Food and Drug Administration unveiled a new effort to bolster its oversight of drugs after they’re on the market, in the agency’s latest response to years of criticism about its handling of medication safety issues. Ultimately, the FDA is supposed to implement a second phase to the plan, called Safe Use, that will focus on ensuring that drugs are used safely in the real world. But the agency official said there were few details available yet about the plan.

Among other changes, the plan, dubbed Safety First involves creating a new database listing possible side effects of drugs, along with clear schedules for following up on questions about them. Also, the FDA plans to make changes to its procedures for making certain regulatory decisions, particularly those based on emerging safety worries, though the new moves don’t go as far as some critics have advocated. The FDA plans to grant some new powers to the office that focuses largely on the safety of marketed drugs, known as the Office of Surveillance and Epidemiology. Republican Sen. Chuck Grassley of Iowa, among others, has raised concerns about the agency’s current decision-making process, because regulatory power over drugs once they are approved rests primarily with the same drug-review divisions that decided to approve them for marketing in the first place. The plan was announced to FDA staff in an email today, and the agency is expected to testify about it tomorrow on Capitol Hill.

The new moves stop short of divorcing the two functions. The safety office will not get the ultimate power to sign off on label changes or recommendations to remove a drug from the market.

The agency will have multidisciplinary groups, including the pre-market review division and the safety office, come together to make decisions. If one office disagrees, it can appeal to higher-level officials. Currently, while this may often occur, it is more ad-hoc. Also, the pre-market drug-review divisions will each get their own new, dedicated officials whose responsibilities focus on safety.

The drug safety office will get primary authority over decisions to approve drug brand names and packaging, though this change will not occur immediately. Eventually, the safety office is supposed to formally get another power as well: the ability to commission certain kinds of research, the epidemiological studies often drawn from patient databases. This could involve requiring drug makers to do such studies — a power the FDA gained under a new law passed last year — or contracting with outside sources.

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No World Borders has developed several service offerings by combining our deep industry experience with pioneering technology and capabilities. We work with our clients to achieve sustainable, long-term, integrated solutions at lower cost aligning strategy with people, processes and technology. We aim for speed to value through extensive experience, pre-packaged materials and fast implementation. Our Health & Life Sciences industry group works with clients to ensure that patient need is at the center of everything they do. Within pharmaceutical and medical products, providers, payers and public service health we are transforming global health care by connecting information, insights and technology to improve the quality of the patient experience. Process improvement is at the forefront of No World Border’s competencies, which are critical in highly regulated industries.

Michael F. Arrigo

Michael is Managing Partner & CEO of No World Borders, a leading healthcare management and IT consulting firm. He serves as an expert witness in Federal and State Court and was recently ruled as an expert by a 9th Circuit Federal Judge. He serves as a patent expert witness on intellectual property disputes, both as a Technical Expert and a Damages expert. His vision for the firm is to continue acquisition of skills and technology that support the intersection of clinical data and administrative health data where the eligibility for medically necessary care is determined. He leads a team that provides litigation consulting as well as advisory regarding medical coding, medical billing, medical bill review and HIPAA Privacy and Security best practices for healthcare clients, Meaningful Use of Electronic Health Records. He advises legal teams as an expert witness in HIPAA Privacy and Security, medical coding and billing and usual and customary cost of care, the Affordable Care Act and benefits enrollment, white collar crime, False Claims Act, Anti-Kickback, Stark Law, physician compensation, Insurance bad faith, payor-provider disputes, ERISA plan-third-party administrator disputes, third-party liability, and the Medicare Secondary Payer Act (MSPA) MMSEA Section 111 reporting. He uses these skills in disputes regarding the valuation of pharmaceuticals and drug costs and in the review and audit of pain management and opioid prescribers under state Standards and the Controlled Substances Act. He consults to venture capital and private equity firms on mHealth, Cloud Computing in Healthcare, and Software as a Service. He advises ERISA self-insured employers on cost of care and regulations. Arrigo was recently retained by the U.S. Department of Justice (DOJ) regarding a significant false claims act investigation. He has provided opinions on over $1 billion in health care claims and due diligence on over $8 billion in healthcare mergers and acquisitions. Education: UC Irvine - Economics and Computer Science, University of Southern California - Business, studies at Stanford Medical School - Biomedical Informatics, studies at Harvard Medical School - Bioethics. Trained in over 10 medical specialties in medical billing and coding. Trained by U.S. Patent and Trademark Office (USPTO) and PTAB Judges on patent statutes, rules and case law (as a non-attorney to better advise clients on Technical and Damages aspects of patent construction and claims). Mr. Arrigo has been interviewed quoted in the Wall Street Journal, New York Times, and National Public Radio, Fortune, KNX 1070 Radio, Kaiser Health News, NBC Television News, The Capitol Forum and other media outlets. See https://www.noworldborders.com/news/ and https://www.noworldborders.com/clients/ for more about the company.

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