By Greg Slabodkin
Rep. Chris Collins is a multimillionaire businessman who owns biotechnology and pharmaceutical companies. Collins knows firsthand what it’s like to be an entrepreneur, which is why as a congressman he is against government regulations that might stunt growth and innovation. As chairman of the House Small Business Subcommittee on Health and Technology, he is an advocate for entrepreneurs who, motivated by the popularity of smart phones and tablets, are developing applications for the rapidly growing field of mobile health care.
On June 27, Collins’ subcommittee held a hearing highlighting the challenging business and regulatory environment that entrepreneurs face as they develop their health apps and try to bring them to market. He and his House Republican colleagues have criticized the U.S. Food and Drug Administration for being slow to release its final guidance on mobile medical apps.
As the federal agency charged with regulating these apps, the FDA issued draft guidance in July 2011 and will finalize these regulations by Sept. 30. That isn’t fast enough for Collins, who argues that two years is too long for investors who are reluctant to sink money into health technologies while the regulatory framework is unclear.
Collins and the FDA have different agendas. He is more concerned with enabling entrepreneurs to cash in on an exploding market. For the FDA, however, safety is paramount and the agency must seriously and soberly assess the regulations and approval process.
We’re not talking about video games or other benign apps. Some of these apps could potentially have serious health implications for those who use them.
A 2012 probe by the New England Center for Investigative Reporting revealed that consumers are being “bamboozled by hucksters” selling apps that claim to cure everything from acne to alcoholism. In its survey of 1,500 apps, the center found that more than 20 percent claim to treat or cure medical problems, many of which do not follow established medical guidelines and have not been clinically tested and in “some cases could even endanger people.”
Consequently, the FDA must be allowed to perform due diligence in finalizing its guidelines. The agency’s clearance process for these apps will serve a critical function in helping physicians and consumers to cut through the marketing hype of companies creating these apps, thereby safeguarding patients and the general public.
As Collins knows very well, profit motive and speed to market drive competition, innovation and entrepreneurship in the health care industry. However, in the case of mobile medical apps, those needs must be balanced against patient safety.
Greg Slabodkin of Kenmore is editor of the online publication FierceMobile-Healthcare.