Tag:Regulation
Proposed Changes to the NIH Guidelines for Human Gene Transfer Experiments
The National Institute of Health (NIH) has submitted a proposal to amend the NIH Guidelinesfor research involving recombinant or synthetic nucleic acid molecules. The proposed amendmentseeks to streamline the oversight for human gene transfer clinical research protocols and reduce duplicative reporting requirements already captured within existing regulatory framework. The amendment specifically seeks to delete the NIH protocol registration submission and reporting requirements under Appendix M of the NIH Guidelines, and modify the roles and responsibilities of entities involved in human gene transfer or the Recombinant DNA Advisory Committee(RAC).
FDA Warns E-Cigarette Manufacturers: Stop Teen Epidemic or Face Consequences
The rise of electronic cigarettes was initially met with relaxed FDA regulation given optimism that they could help adult smokers curb use of more toxic combustible cigarettes. This optimism was in spite of e-cigarettes’ growing popularity among adolescents and young adults. On September 12, the FDA signaled a pivot from this approach when FDA Commissioner Scott Gottlieb described youth e-cigarette use as having reached epidemic proportions. Gottlieb announced that the FDA had issued more than 1,300 warning letters and fines to retailers caught selling e-cigarette products to minors. It also issued an order to the five major e-cigarette manufacturers (Juul, Vuse, Blu, MarkTen XL, and Logic) to each submit a plan outlining how the company will address youth access and use of their products. Failure to submit a sufficient plan could lead the FDA to revisit its earlier decision on flavored e-cigarette products, which allowed manufacturers a grace period until 2022 to receive FDA approval.
Methane Emission Regulation Newest Proposed Target for EPA Rollbacks
On August 29, 2019, the Environmental Protection Agency (“the EPA”) announced a proposed reconsideration amendment to an Obama Administration rule regulating the natural gas industry’s methane emissions. This proposal is in response to President Trump’s order for federal agencies to review their actions, purportedly to remove potential resource burdens. The EPA asserts that the changes will remove regulatory duplication and save the industry millions of dollars, but the savings may come at the expense of increasing the planet’s vulnerability.
“Grounding”: Federal Regulation in the Context of Aircraft Suspensions
On March 10, 2019, Ethiopian Airlines Flight 302 en route to Nairobi, Kenya crashed shortly after take-off leaving no survivors. It became the carrier’s most deadly crash and its first fatal crash since January 2010. Most notably, however, it was the second fatal crash involving Boeing’s new 737 MAX jet in less than five months after the Lion Air Flight 610 accident in October 2018. The day following the tragedy, Ethiopian Airlines grounded all of its Boeing 737 MAX 8 fleet until further notice. Many other airlines suspended operations of the aircraft as well and countless countries banned the 737 MAX from airspace.
Data Privacy Rules Step Up to the Next Level
The Federal Trade Commission (“FTC”) recently proposed two amendments to the Privacy Rule and Safeguards Rule under the Gramm-Leach-Bliley Act (“GLBA”). The Safeguards Rule requires financial institutions to develop, implement, and maintain a comprehensive information security system. This rule went into effect in 2003. The Privacy Rule requires financial institutions to inform customers about its information-sharing practices and allows customers to opt out of having their information shared with certain third parties. This rule went into effect in 2000. The recent amendments to these two rules are intended to further protect consumers’ data from third parties. However, the changes could also adversely affect businesses.
The Future of Online Prescribing
Telehealth allows for the delivery and facilitation of medical services through technology. It is rapidly evolving as the tech industry grows. Ten years after the passage of the Ryan Haight Act, the Drug Enforcement Agency (DEA) has still not taken any action to assist physicians in their usage of telehealth. Recently, Congress finally stepped in and passed a bill that requires the DEA to take action within the next year. But, the question still remains whether the DEA will finally act, or continue their history of avoidance?
Proposed Changes to the Clinical Laboratory Improvement Amendments of 1988
The Department of Health and Human Services Center for Medicare and Medicaid Services have proposed a ruleto update the proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The new rule seeks to address current analytes, substances or constituents for which the laboratory conducts testing, and newer technologies. The rule would further make technical changes to the PT referral regulations to be more closely aligned with the CLIA statute.
HIPAA May Not Be Enough to Protect Our Health Information
On March 1, 2019, the College of Healthcare Information Management Executives (“CHIME”) sent a six-page letter to Congress which discussed how technology has impacted health care costs. CHIME believes that too much money is being allocated towards making sure that health care organizations are complying with the Office of Civil Rights (“OCR”) and the Department of Health and Human Services (“HHS”) requirements, while not enough resources are being given towards actually protecting against cybersecurity attacks. The letter contains multiple suggestions in which patient data could be better protected, such as incentivizing health care organizations to implement more cybersecurity safety measures. However, many of CHIME’s proposals would require Congress to amend multiple provisions in acts, such as the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH Act”).
The Ugly Side of Beauty: How Under-Regulation of Cosmetics Harmed Consumers for Decades
It is no secret that the beauty industry in America is frighteningly under-regulated. Cosmetics companies and beauty brands have managed to escape meaningful regulatory oversight for roughly a century and are largely left to self-regulate. In 2017, the global cosmetic products market was valued at $532 billion and is expected to reach a market value of $806 billion by 2023, registering a compound annual growth rate of 7.14%. Despite the colossal financial growth, regulatory shortcomings leave much to be desired by consumers. On the back of numerous harmful side-effects scandals and multi-million dollar class-action settlements, the FDA must grapple with renewed demand for cosmetics regulation as new beauty trends emerge.
Sunscreen Regulations: Providing Protection for Consumers and Difficulties for Manufacturers
In 2014, Congress passed the Sunscreen Innovation Act in the hopes of encouraging innovation for new sunscreen ingredients. Recently, the United States Food and Drug Administration (FDA) proposed new regulations regarding over-the-counter sunscreens to keep up with recent scientific and safety information. This proposal will be available for ninety days from its announcement on February 21, 2019, and addresses safety concerns of common sunscreen ingredients. Further, the proposal addresses the labeling of sunscreen, trying to make it easier for consumers to identify the product information. While this proposal seeks to alleviate safety concerns, the regulation could potentially make it more difficult for new ingredients to be approved.