According to an article published in The Cybersecurity Source in 2016, over 90% of regulatory data collected for submission to the FDA is electronically transmitted and potentially accessible to hackers. Because of increased use of electronic technology for data collection, such as electronic health records, there is increased risk of hackers gaining access to confidential and proprietary information.
Why is this so important for the pharmaceutical industry? For one thing, the added cost of protecting data from hackers can increase medication prices, which are then passed onto the consumer. In some cases, companies spend billions of dollars to bring a drug to market, not to mention that it can take many years to develop a new medication. Since the FDA now receives much of its information about intellectual property via electronic transmissions, it is imperative that strict security standards be applied to the FDA data-submission process. The FDA is dedicated in its strategic plan to improve on the agency’s quality, security, and efficiency.
According to an article in the Cybersecurity Source, the FDA actually provided a detailed IT strategy aimed at strengthening the protection of pharmaceutical company data submitted during a new drug approval filing. Yet, given the recent onslaught of hacking throughout the healthcare system, the “hacking business” seems to be penetrating every aspect of the pharmaceutical-development process from the inception of a drug concept to its final approval.
The FDA’s latest Information Technology Strategic Plan aims to roll out verification and validation for high-risk systems and next-generation network security architecture, and will improve the agency’s patch-management plan. A report published in April 2016 noted an increase in cyber incidents targeting the manufacturing sector, including pharmaceutical companies, attributed to an overall increase in hackers seeking intellectual property.
So why does all this matter to the pharmacies and patients? Pricing is a big factor, as well as integrity of the pharmaceuticals and the ability of the industry to deliver new therapies. The more cumbersome and complex the process of bringing a new therapy to market becomes, the more difficult it becomes it is to bring these new treatments to the consumer.
For pharmacies wishing to deliver the highest quality therapeutics, it is imperative that the process for submitting electronic data to the FDA be streamlined and secure. The speed to market of a new therapy affects us all—from its clinical development to dispensing. If pharmaceutical companies need to worry about securing data to ensure competitive advantages, the cost of protecting this data will inevitably create increased cost, which is ultimately passed to patients.
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