Do you remember in high school when your civics teacher discussed the differences between the legislative, executive, and judicial branches of the government? If you decided to play hooky, sleep through class, or forgot what was discussed long ago, you are not alone; the President, a former law professor, is proposing to usurp the power of Congress to create laws by revising the Medical Device Regulation Act of 1976.
The legislative branch consists of elected members of the Senate and House of Representatives who ponderously create laws, and the executive branch consists of the President and the millions of functionaries he appoints to execute laws. The judiciary interprets laws and limits the other branches by determining whether laws passed by the legislature and the actions of the executive conform to the Constitution, but does so infrequently because judges are appointed by the President and confirmed by the legislature.
What amusing sequence of events occurs after the executive branch executes a law that harms a constituent of the New Jersey legislative delegation? This occurred recently in the case of FDA functionaries interpreting a law that requires the maker of a “new” medical device to endure an onerous expensive ordeal, which often prevents useful and innovative devices from being introduced, that is not required of makers of “old” devices.
As the functionaries ruled, the device was new, but the manufacturer wanted to sell to customers begging for their product, so they bribed the legislators with political campaign contributions, who served their constituent by lobbying the FDA, which reversed course by ruling that the new device was old, and so not subject to the onerous process that would practically prevent it from being sold to the begging potential customers.
The Wall Street Journal shined a light on the imbroglio, so a scandal ensued because the executive is required to faithfully execute laws, instead of arbitrarily exempting the politically powerful. The outrage was great, so the FDA rescinded their decision (reversing itself a second time!), reopening the process determining whether the device is classified as new or old, or more precisely, “substantially equivalent” to a device prior to 1976.
The FDA conceded that they failed their mission to protect begging potential customers from eager sellers. Essentially, they perceive their role as similar to Underwriters Laboratories, Consumer Reports, and magazine product reviewers in helping or “protecting” potential buyers. However, unlike private companies that change their name or declare bankruptcy and cease operations after an embarrassing failure, the FDA proposes the opposite: an expansion of power and a budget increase.
The FDA proposes new laws, to be enacted by the executive branch rather than the legislative branch as required by the Constitution, that would place more obstacles between buyers and sellers. Currently, there are 3 classes of medical devices, appropriately named I (low risk), II (medium risk), and III (high risk); so the FDA proposes a fourth, which would be called IIb, breaking the Roman numeral pattern because they anticipate that medical devices in the fourth category would be consist of those that under the previous classification had been class II or III.
Class I devices encompass mundane products like dental floss, tongue depressors, and heating pads. A class III device maintains or supports life, and requires proof of safety and effectiveness before the President will allow it to be sold. A class II device does not maintain or support life, but is not as mundane as class I.
The proposed IIb classification would include products that would be heavily regulated in the first few years after introduction, and later be reclassified as class IIa after the product matures. This could be beneficial to copycat vendors, who will spared the great regulatory expenses incurred by a pioneer, but it might retard the development of new products.
The “510(k) Working Group Preliminary Report and Recommendations” are open to public comment, “including the feasibility of implementation and
potential alternatives.” It is likely that many comments will be submitted by medical device manufacturers, and by proponents of expanded government power such as Public Citizen, which asserts, “We are the countervailing force to corporate power. We fight on behalf of all Americans to make sure your government works for you.”
A second related report, “Task Force on the Utilization of Science in Regulatory Decision Making Preliminary Report and Recommendations” is also open to public comment. This report advocates a budget increase so that the FDA can hire more scientists to help them understand new technology.
The reports are not written in language that an ordinary person can understand, so the general public is unlikely to comment on issues such as the separation of power between the executive and legislative branches, or whether a paternalistic government that seeks to “protect” citizens is desirable.
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