In Bath County, Kentucky, a rural area near Lexington, a judge sentenced a 57-year-old Amish farmer and father of 12 to six years in prison for producing a herbal skin cream without the government’s permission.
Samuel Girod formulated homemade skin-care products on his family farm, and sold them for two decades throughout the upper Midwest, largely on word-of-mouth promotion. He claimed that his products could help with poison ivy rashes, psoriasis, headaches, and more. Despite the fact that the products were made from benign, natural ingredients like chickweed, rosemary, olive oil, and peppermint, products intended to treat diseases are considered drugs and must be approved by the Food and Drug Administration and produced in an approved facility.
Continue reading at The Daily Beast
Last week, the Senate Committee on Health, Education, Labor, and Pensions met to consider legislation that would reauthorize the Food and Drug Administration’s (FDA) user fee programs. These programs make up a large part of the agency’s budget. This process will continue over the next several weeks.
Earlier this month, the House Committee on Energy and Commerce also held a hearing to consider improvements to the regulation of medical technologies. This will most likely become a part of the reauthorization legislation. While an admirable goal, the true goal that policy makers should pursue is to create an environment in which innovation and entrepreneurship can thrive with as few barriers as possible.
Continue reading in RealClearHealth
Last Wednesday, Uber announced that residents of San Francisco could call rides in autonomous vehicles. In response, the CaliforniaDepartment of Motor Vehicles issued a cease-and-desist letter to Uber saying that their testing of autonomous vehicles was illegal. This display of the “precautionary principle,” though well-intentioned, hurts entrepreneurship. To foster innovation and growth of self-driving vehicles, California should allow Uber to test its cars and rely on the legal system to provide redress for any harms.
In their letter to Uber, the California DMV said:
“California Vehicle Code Section 38750 and California Code of Regulations Article 3.7 clearly establish that an autonomous vehicle may be tested on public roads only if the vehicle manufacturer, including anyone that installs autonomous technology on a vehicle, has obtained a permit to test such vehicles from the DMV.”
However, Uber’s vehicles are not considered autonomous vehicles under the laws referenced in the letter. California Vehicle Code Section 38750 defines an autonomous vehicle as “any vehicle equipped with autonomous technology that has been integrated into that vehicle.” And it defines autonomous technology as “technology that has the capability to drive a vehicle without the active physical control or monitoring by a human operator.” The code also defines an operator as “the person who is seated in the driver’s seat.”
Continue reading at San Francisco Examiner.