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FCC Republican Rejects Data Cap Regulations, Equating Them to Restrictions on Coffee Refills

# FCC’s Investigation into Broadband Data Restrictions: A Growing Controversy

The Federal Communications Commission (FCC) has embarked on a formal investigation concerning the effects of broadband data restrictions on users and market competition. This initiative, spearheaded by FCC Chairwoman Jessica Rosenworcel and backed by the Democratic majority, seeks to tackle rising consumer dissatisfaction regarding data restrictions set by Internet Service Providers (ISPs). However, this investigation is encountering resistance from the FCC’s Republican commissioners, who contend that oversight of data restrictions equals rate regulation, which they oppose.

## The Consumer Discontent with Data Restrictions

Data restrictions, which cap the quantity of data consumers can utilize each month before incurring extra fees or experiencing slower speeds, have consistently frustrated many Internet users. Rosenworcel reports that nearly 3,000 consumers lodged complaints with the FCC regarding data restrictions in the past year alone. These complaints underscore the tangible effects of data restrictions, particularly on families and individuals dependent on the Internet for their work, education, and entertainment needs.

In her statement, Rosenworcel highlighted the psychological and financial strain that data restrictions place on consumers. “The psychological burden of constantly worrying about how much you use a service that is vital for contemporary life is significant,” she stated. One complaint, from a resident of Arkansas, recounted how their family had to disconnect their modem to avoid surpassing the data limit and opted for public Wi-Fi for their children’s educational work.

The FCC’s investigation aims to collect additional insights into how data restrictions influence consumers and whether these limits are warranted, considering the capabilities of current broadband networks. Throughout the COVID-19 pandemic, several ISPs temporarily lifted data restrictions, indicating that networks can accommodate higher levels of usage without such constraints.

## The Republican Dissent: A Coffee Shop Metaphor

As the FCC’s Democratic majority advocates for the investigation, the Republican commissioners—Nathan Simington and Brendan Carr—have expressed vehement disapproval. Simington, in particular, employed an imaginative metaphor to argue against the regulation of data restrictions. He compared the FCC to a hypothetical “Federal Coffee Commission” that might mandate coffee shops to provide free refills. Simington argued that such a regulation would result in unforeseen repercussions, including increased prices for coffee overall or the disappearance of smaller, more budget-friendly coffee options.

Simington further related this metaphor to broadband networks, positing that tiered pricing structures (like data restrictions) enable ISPs to earn additional revenue that can be reinvested into network enhancements. He cautioned that overseeing data limits could lead to higher costs for all consumers, not merely those who exceed their data thresholds. “Though it is merely a Notice of Inquiry, because it is the initial step down a path toward more extensive rate regulation, I cannot endorse the item we’ve concocted here,” Simington noted in his dissent.

Carr resonated with Simington’s concerns, arguing that plans with data limits are frequently more economical compared to unlimited options and that banning such plans would constitute rate regulation. He also referenced a recent court decision that obstructed the FCC’s bid to reinstate net neutrality regulations, implying that the FCC lacks the legal latitude to oversee data restrictions.

## The Legal Dilemma: Is the FCC Empowered to Regulate Data Restrictions?

A crucial inquiry in the FCC’s investigation revolves around whether the commission possesses the legal authority to regulate data limitations. The FCC’s Notice of Inquiry requests public feedback on various potential authoritative sources, including Section 257 of the Communications Act of 1934, which discusses market entry obstacles, and Section 706 of the Telecommunications Act of 1996, which emphasizes promoting broadband deployment.

The FCC is also examining the possibility of utilizing its spectrum licensing authority to address data limits on mobile broadband services. Nevertheless, the commission concedes that it remains uncertain regarding its capacity to take significant action on regulating data restrictions. The investigation may eventually yield a compilation of information rather than new regulatory measures.

## The Way Forward: Collecting Information and Public Perspectives

The FCC is currently inviting public feedback regarding the ramifications of data restrictions and the commission’s possible authority to regulate them. The initial round of comments is open until November 14, with responses due by December 2. The investigation will concentrate on grasping the existing landscape of data restrictions, their effects on consumers, and whether regulatory measures are necessary.

Rosenworcel has made it apparent that this investigation marks merely the commencement of a more extensive initiative to address consumer issues. “We are going to delve into this with this investigation,” she stated. “We will clarify what is transpiring currently and what actions we can pursue next; we are committed to ensuring that the consumers who reach out to us are acknowledged.”

## Conclusion

The FCC’s investigation into broadband data restrictions has ignited a spirited debate between the commission’s Democratic and Republican members. While Democrats assert that data restrictions are an undue burden on consumers, Republicans caution that overseeing these limits could result in escalating prices and diminished consumer options. The outcome of the investigation remains uncertain, but it signifies a vital step toward addressing the escalating concerns.

FDA Changes Course, Permitting Drug Manufacturers to Keep Creating Off-Label Weight-Loss Drugs

# FDA Reexamines Its Choice to Remove Tirzepatide Drugs from Shortage List Following Lawsuit

The U.S. Food and Drug Administration (FDA) is reassessing its decision to take tirzepatide-based medications, including Eli Lilly’s Mounjaro (for diabetes) and Zepbound (for weight loss), off the national shortage list. This reexamination comes as a result of a lawsuit initiated by a trade organization advocating for compounding pharmacies, which asserts that the shortage of these medications continues even after the FDA’s prior announcement that supply issues had been addressed.

## Overview of Tirzepatide and Its Demand

Tirzepatide belongs to the glucagon-like peptide-1 (GLP-1) receptor agonist class of drugs, which has attracted significant attention due to its effectiveness in treating both type 2 diabetes and obesity. Mounjaro, originally approved for diabetes treatment, and Zepbound, utilized for weight management, have become extremely popular medications because of their effectiveness in helping patients control blood sugar levels and achieve substantial weight loss.

The high demand for these drugs has resulted in a notable increase in need, consequently leading to supply shortages. In December 2022, the FDA included tirzepatide medications on its national shortage list, thereby permitting compounding pharmacies to create more affordable, copycat versions of the drugs. Compounding pharmacies, or outsourcing facilities, can lawfully manufacture imitation versions of FDA-approved drugs only when those drugs are officially recognized as being in short supply.

## FDA’s Action to Delist Tirzepatide from the Shortage List

On October 2, 2024, the FDA declared that tirzepatide drugs were no longer deemed to be in short supply. The agency referenced assurances from Eli Lilly, the producer of Mounjaro and Zepbound, indicating that its production ability could satisfy both current and anticipated national needs. Nevertheless, the FDA did concede the possibility of “intermittent localized supply interruptions.”

The determination to remove tirzepatide from the shortage list meant that compounding pharmacies were instantly restricted from producing any additional quantities of the drug. They were granted a 60-day period to complete existing orders, after which they would be prohibited from manufacturing the compounded forms.

## Lawsuit and FDA’s Reassessment

Following the FDA’s decision, the Outsourcing Facilities Association (OFA), representing compounding pharmacies, initiated a lawsuit against the agency. The legal action contended that the shortage of tirzepatide drugs remained and that the FDA had relied exclusively on Eli Lilly’s assurances, which the OFA argued were self-serving and intended to monopolize the market.

The lawsuit prompted the FDA to reassess its determination. In a court submission on October 13, 2024, the FDA sought to pause the lawsuit to give the agency time to reexamine its decision regarding the removal of tirzepatide from the shortage list. The FDA referenced previous court decisions that allow agencies to rectify their own errors before further legal actions ensue.

As part of this review process, the FDA also committed to refraining from taking any regulatory enforcement measures against compounding pharmacies that continued to produce tirzepatide-based drugs while the review continued. This approach effectively permits compounding pharmacies to keep manufacturing the drugs until a conclusive decision is reached.

## Responses from Stakeholders

### Compounding Pharmacies and Patients

The FDA’s decision to revisit its position was positively received by the Outsourcing Facilities Association. OFA Chairperson Lee Rosebush expressed contentment with the outcome, stating, “We believe that this is a fair resolution in light of the agency’s hasty decision to remove the drug from the list when the agency has acknowledged ‘supply disruptions,’ which immediately created a significant access issue for patients everywhere.”

For patients dependent on the more affordable, compounded tirzepatide versions, the FDA’s reexamination is likely to be a relief. Numerous patients, particularly those lacking comprehensive insurance, have turned to compounded drugs as a cost-effective alternative to the brand-name options. For some, compounded formulations may have been their sole means of accessing tirzepatide.

Nonetheless, the FDA has consistently cautioned that compounded drugs lack FDA approval and do not undergo the same stringent safety, efficacy, and quality evaluations as their brand-name equivalents. The agency has expressed concerns regarding dosing mistakes and other safety challenges linked to compounded variations of GLP-1 medications.

### Eli Lilly’s Reaction

Eli Lilly, the developer of Mounjaro and Zepbound, has conveyed dissatisfaction with the FDA’s reconsideration. The company had previously issued cease-and-desist notices to compounding pharmacies, asserting that the shortage had been addressed and that there was no necessity for compounded iterations of the drugs.

In a statement to Ars Technica, a representative for Eli Lilly reiterated that the company’s supply of tirzepatide was adequate to meet demand and emphasized that compounded versions were unwarranted. The