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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Michael F. Arrigo

Michael Arrigo brings four decades of experience in the software, financial services, and healthcare industries. In 2000, Mr. Arrigo founded No World Borders, a healthcare data, regulations, and economics firm with clients in the pharmaceutical, medical device, hospital, surgical center, physician group, diagnostic imaging, genetic testing, health IT, and health insurance markets. His expertise spans the federal health programs Medicare and Medicaid and private insurance. He advises Medicare Advantage Organizations who provide health insurance under Part C of the Medicare Act. Mr. Arrigo serves as an expert witness regarding medical coding and medical billing, fraud damages, as well as electronic health record software for the U.S. Department of Justice. He has valued well over $1 billion in medical billings in personal injury liens, medical malpractice, insurance fraud cases. The U.S. Court of Appeals considered Mr. Arrigo's opinion regarding loss amounts, vacating, and remanding sentencing in a fraud case. Mr. Arrigo provides expertise in the Medicare Secondary Payer Act, Medicare LCDs, anti-trust litigation, medical intellectual property and trade secrets, HIPAA privacy, health care electronic claim data Standards, physician compensation, Anti-Kickback Statute, Stark law, the Affordable Care Act, False Claims Act, and the ARRA HITECH Act. Arrigo advises investors on merger and acquisition (M&A) diligence in the healthcare industry on transactions cumulatively valued at over $1 billion. Mr. Arrigo spent over ten years in Silicon Valley software firms in roles from Product Manager to CEO. He was product manager for a leading-edge database technology joint venture that became commercialized as Microsoft SQL Server, Vice President of Marketing for a software company when it grew from under $2 million in revenue to a $50 million acquisition by a company now merged into Cincom Systems, hired by private equity investors to serve as Vice President of Marketing for a secure email software company until its acquisition and multi $million investor exit by a company now merged into Axway Software SA (Euronext: AXW.PA), and CEO of one of the first cloud-based billing software companies, licensing its technology to Citrix Systems (NASDAQ: CTXS). Later, before entering the healthcare industry, he joined Fortune 500 company Fidelity National Financial (NYSE: FNF) as a Vice President, overseeing eCommerce solutions for the mortgage banking industry. While serving as a Vice President at Fortune 500 company First American Financial (NYSE: FAF), he oversaw eCommerce and regulatory compliance technology initiatives for top ten mortgage banks and led the Sarbanes Oxley Act Section 302 internal controls IT audit for the company, supporting Section 404 of the Sarbanes Oxley Act. Mr. Arrigo earned his Bachelor of Science in Business Administration from the University of Southern California. Before that, he studied computer science, statistics, and economics at the University of California, Irvine. His post-graduate studies include biomedical ethics at Harvard Medical School, biomedical informatics at Stanford Medical School, blockchain and crypto economics at the Massachusetts Institute of Technology, and training as a Certified Professional Medical Auditor (CPMA). Mr. Arrigo is qualified to serve as a director due to his experience in healthcare data, regulations, and economics, his leadership roles in software and financial services public companies, and his healthcare M&A diligence and public company regulatory experience. Mr. Arrigo is quoted in The Wall Street Journal, Fortune Magazine, Kaiser Health News, Consumer Affairs, National Public Radio (NPR), NBC News Houston, USA Today / Milwaukee Journal Sentinel, Medical Economics, Capitol ForumThe Daily Beast, the Lund Report, Inside Higher Ed, New England Psychologist, and other press and media outlets. He authored a peer-reviewed article regarding clinical documentation quality to support accurate medical coding, billing, and good patient care, published by Healthcare Financial Management Association (HFMA) and is published in Healthcare IT News.

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