Category:

Drugs & Devices

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.

Health and Human Services Promulgates New Abortion “Gag” Rule; Opponents Prepare for Legal Challenges

On February 22, 2019, the Department of Health and Human Services submitted a final rule to the Federal Register, substantially altering existing guidelines for family planning programs’ reception of federal funds under Title X of the Public Health Service Act (PHS Act). Among other things, the new regulations prohibit qualifying programs from referring patients to abortion providers. Public statements from organizations such as Planned Parenthood suggest lawsuits for injunctive relief are imminent.

Senators Urge FDA to Update Its Regulation on Products Containing Hemp and Hemp-derived Compounds

On January 15, 2019, Senators Ron Wyden and Jeff Merkley sent a letter to the U.S. Food and Drug Administration (FDA) urging the agency to update its federal regulations governing the use of certain cannabis-derived ingredients in food, beverages and dietary supplements. As writers of the Hemp Farming Act, Wyden and Merkley, initiated the removal of the hemp plant and derivatives of Cannabis sativa from the list of controlled substances under the Controlled Substance Act. The Hemp Farming Act passed as a provision in the Agriculture Improvement Act of 2018, and thus, legalized the production and sale of industrial hemp and hemp-derived compounds, including cannabidiol (CBD).

The Years Long Process to a Revised Common Rule and Implementation

The Common Rule, the Federal policy protecting human subjects of biomedical and behavioral research, was published in 1991. The process to update the policy has taken place over the last several years, leading to the final rule revisions which were effective as of July 19, 2018. After January 20, 2019, institutions are now permitted to implement the entirety of the revised Common Rule. Any institution receiving funds, supervision, or review from any of the twenty Federal Departments and Agencies that have codified the Common Rule must implement this revised rule in their compliance programs.

Injunctions Halt Trump Administration’s Attempt to Expand Religious Exemption for Obamacare Contraceptive Mandate

A pair of injunctions in the Northern District of California on January 13, and the Eastern District of Pennsylvania on January 14, halted the implementation of amendments to a religious exemption to the so-called contraception “mandate” of the Affordable Care Act, also known as Obamacare. The “mandate” requires most employers to include contraception coverage in the insurance plans they offer to employees. While Obama administrative agencies contemplated religious exemptions early on, contentious litigation and political transition expanded the scope of the exemption until these latest developments.

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.

FDA Declares War on Flavored E-Cigarette

In July 2017, the Food and Drug Administration revealed a new policy that sought to reduce the deaths and diseases caused by smoking which takes nearly 500,000 lives annually in the United States. In early September 2018, the FDA followed up on its mission by unveiling a plan to address the e-cigarette epidemic. E-cigarettes, and in particularly, a brand of flavored e-cigarettes called “JUULs,” have taken the teenage and adolescent market by storm. While the FDA is primarily concerned with reducing the overall number of smoking-related casualties, it notes a particular concern for a vulnerable young demographic and the effects of nicotine intake on a developing brain.

A Way Around HHS 340B Program Delays

Access to quality, comprehensive health care services seems to always be at the forefront of our health care industry. One’s ability to gain access measured in terms of utilization, is dependent upon financial affordability, and physical accessibility. While a seemingly small issue under the overarching ‘access to health care’ topic, talks about access to medication and its affordability in particular for the vulnerable and underinsured patients must also be addressed. A number of health organizations have sued HHS for delaying the implementation of rules that would force drug companies to be transparent about their pricing and punish them for overcharging participating hospitals in the federal program that discounts outpatient medication. Due to HHS’ delays, hospitals cannot challenge drug manufacturers for overpricing outpatient medication thus they cannot access refunds of discounts that are due to them under statute. 

FDA Faces Forward with Flexible Genetic Guidance

In recent years, the FDA has examined a record number of revolutionary medical devices, many of which have been genetic tests. Genetics has taken the world by storm. The medical world continues to look toward genetics as a promising next step in revolutionizing treatment, while the American public has shown a growing interest in learning more about themselves through services like Ancestry and 23andMe. In an effort to gain a foothold on the rapidly developing field of technology, the FDA has recently made efforts to modernize its approach by issuing new guidance to ensure the validity of these tests.