I want to welcome Kara Zupkus to the growing Taxpayers Protection Alliance (TPA) team.  We are super excited to have her on board as TPA’s new Communications Manager.  Kara comes to TPA from Congressman Dan Crenshaw’s office where she served as Director of Communications, and prior to serving Texas’ 2nd District oversaw digital and media strategy for Young America’s Foundation (YAF).  Kara is a passionate free-market communicator and hit the ground running this week with a statement and outreach on the Federal Communications Commission’s misguided return to Net Neutrality regulations.

Net Neutrality – If it Ain’t Broke, Don’t Fix it

The Federal Communications Commission (FCC) voted along party lines Thursday to move forward with plans to reinstate Title II rules on internet providers under the Communications Act of 1934. The 3-2 tally (under the lead of Chairwoman Jessica Rosenworcel with all three Democratic commissioners voting for the order) is the first step in classifying the internet as a common carrier service. The FCC put these onerous and unnecessary regulations on broadband providers between 2015 and 2017 before former Chairman Ajit Pai led the effort to eliminate them.  Title II, or “net neutrality,” continues to be “a solution that won’t work to a problem that doesn’t exist,” as former FCC Chairman Ajit Pai framed it before helping to repeal the reclassification in 2017. The past six years have shown us that the hysteria from the left about the downfall of the internet did not come to pass. A Taxpayers Protection Alliance Foundation (TPAF) investigation after the so-called net neutrality rules were removed found very few instances of throttling or blocking traffic by providers.

Investment into broadband infrastructure previously dropped by 20 to 30 percent between 2011 and 2015 in the years that former President Barack Obama took office and then-FCC Chairman Julius Genachowski began discussing the Title II reclassification, which was ultimately passed under former Chairman Tom Wheeler. Investment increased after the FCC moved the classification of the internet back under Title I. U.S. Telecom – The Broadband Association reported last year that 2021 saw a 20-year high of $86 billion for capital expenditures into the nation’s communications infrastructure. Many speculate that this maneuver by the FCC is a way to impose rate regulation on the internet.  That is clearly not needed because in a time of rampant inflation, broadband rates have actually fallen 12 percent since 2017, according to the U.S. Bureau of Labor Statistics’ Consumer Price Index. Consumers can thank increased investment for much faster speeds over the past five years. Ookla reports that since 2018, fixed broadband speeds have increased by 300 percent, from 94 Megabits per second to 270 Mbps, while mobile broadband speeds have jumped 570 percent, from 27.5 Mbps to 156.5 Mbps. The light-handed touch by government has allowed innovation to flourish with providers using a variety of methods that include fiber, cable, wireless, fixed wireless and satellite to provide broadband coast-to-coast. Only about 2 percent of Americans now lack access to broadband due to the increased investment in fixed and wireless infrastructure. Bringing back Title II will surely slow efforts to close the high-speed internet gap by dropping investment in broadband once again.
 
Rather than stymie the effort to connect the rest of Americans with broadband with this misguided Title II quest, the FCC should instead help cut red tape and work to improve broadband mapping so that the $100 billion-plus in federal taxpayer dollars now being spent on high-speed internet can most efficiently and effectively be used. 
 
Lab Test Regulation
 
Millions of consumers take for granted laboratory medical tests to diagnose cancers, analyze blood composition, and ensure pregnancies are going smoothly. If the Food and Drug Administration (FDA) moves forward with proposed regulations, lab innovation may soon grind to a halt. The FDA is proposing to treat these tests the same way it treats medical devices, ensuring that simple lab tests would have to be cleared in advance by regulators. This would (at the very least) ensure more paperwork and at worst result in an onerous pre-market review process currently applied to medications, pacemakers, and deep-brain stimulators. Instead of doubling down on onerous regulations, the FDA should embrace innovation and flexibility.
 
The road to lab-grown regulation began a half-century ago, when Congress passed the Medical Device Amendments of 1976. These amendments to the Food, Drug, and Cosmetic Act imbued the FDA with the authority to regulate “medical devices,” a category of products ranging from dental floss to computed tomography (CAT) scanners. Depending on what category (or “class”) the products fall into, the agency could demand pre-approval clinical trials or require the maker to analogize the device to a previously approved device. The FDA spared lab tests from this expensive and complicated system, using “enforcement discretion” to keep these products shielded from scrutiny. But, according to the agency, things have changed in recent decades. In its proposed rule, the FDA claims that lab tests “are generally, among other things, used more widely, by a more diverse population, with an increasing reliance on high-tech instrumentation and software, and more frequently for the purpose of guiding critical health care decisions.”  While this is true, it is actually an argument for greater permissiveness. The FDA ignores the role that a light-touch regulatory approach plays in fostering the development of high-tech testing. For example, the biotechnology company Grail recently pioneered a high-tech, multi-cancer early detection test performed via liquid biopsies. While Grail was able to develop its lifesaving technology relatively free from regulatory scrutiny, it is now fighting for its life against an overzealous Federal Trade Commission (FTC) helmed by Chair Lina Khan. The FTC believes that Grail combining with testing/sequencing company Illumina would cripple the market, despite the efficiency and funding gains that test developers would get from partnering up with sequencers. In waging war against Grail, regulators are sending a message to test providers that attempts to grow their product market will be met with an iron wall of bureaucratic resistance.
 
Even if providers aren’t deterred from trying to enter the market, the FDA pre-market process ensures that products will be delayed at a high price. For example (in 2022), the FDA rejected a drug called omburtamab, designed to treat a rare pediatric brain cancer. Regulators expressed alarm that the data set provided by the drug’s producer contained some information collected during the 1990s and early 2000s when cancer treatments may have been less effective. The agency extensively communicated these concerns with its advisory committee, concluding that the FDA “cannot reliably attribute the observed [overall survival] OS difference to omburtamab.” Yet in the same analysis, the FDA reported that it was in fact able to control for patients’ use of other treatments (i.e., radiation therapy, surgery, chemotherapy) and the time period of treatment. Even after adding the controls, the results appear encouraging for the medication. The data suggest that patients taking omburtamab live seven to 12 months longer than their non-medicated peers. Despite these sustained positive findings, the advisory committee bought into the FDA’s critical briefing and voted to reject the drug. The FDA followed suit and sent Y-mAbs Therapeutics a rejection letter. As the Taxpayers Protection Alliance noted in a 2023 report (analyzing 2022 drug approvals), this risk-averse mentality plagues drug approvals and hampers innovation across the life sciences sector. Patients cannot afford the same approach exported to lab tests.
 
Laboratory medical tests can save millions more lives, but only if regulators stay out of the way and let innovation win the day.