Tag:

FDA

Life or Death: The Fast Track to FDA Approval

After five years, the Food and Drug Administration (FDA) has approved a drug for ALS (amyotrophic lateral sclerosis): Relyvrio. While the drug is expected to significantly prolong the life of ALS patients, who typically die within a few years after diagnosis, the fast approval of the drug raises concerns regarding the FDA’s fast-tracking process of approval.

Agency Officials Trade Stock in Companies their Agencies Oversee

More than 2,500 government officials ranging from the Commerce Department to the Treasury Department reported owning stock in companies whose share prices correspond to decisions made by their respective agencies. With obvious conflicts of interest arising, what has happened, and what are some major takeaways from this investigative report?

FDA’s Response to Baby Formula Shortage

This year the Food and Drug Administration (FDA) has come under fire for its slow response to the nationwide baby formula shortage. In September 2022, FDA Commissioner Robert M. Califf authorized the release of an internal report. The report details how the baby formula shortage occurred, the FDA’s response to the shortage, and the challenges it faced in resolving the shortage. The report also revealed the changes in FDA regulatory procedure to ensure another shortage does not occur. 

A New FDA Rule Will Change the Future of the Hearing Aid Industry

Thanks to a new FDA final rule, published in August of this year, Americans can soon purchase specific hearing aids over-the-counter (OTC) without a hearing exam, prescription, or fitting. Although this rule will improve access to hearing aid devices and lower the costs for those with hearing impairments, many critics are convinced the rule will do more harm than good.

The Discriminatory Policies against Gay and Bisexual Men that are Fueling the National Blood Crisis

This past January, the American Red Cross announced that the United States was facing its worst blood shortage in over a decade, posing a significant risk to patient care and causing doctors to make difficult decisions in determining which patients should be prioritized for blood transfusions given the dwindling supply. The staggering decrease in blood and platelet donations can be attributed to the global COVID-19 pandemic driving up the need for donations and the hesitancy people have had to leave their homes over the past two years. Even in this desperate time of need for blood, gay and bisexual men in America are still prevented from donating because of discrimination.

What the Cluck is Going on? Regulatory Failures Amid a Nationwide Food Poisoning Epidemic

In October 2021, ProPublica published an article about a rare and virulent strain of salmonella infantis outbreak that occurred in May 2018, afflicting at least a dozen people across the country. Many who reported being sick reported that they ate chicken, and federal food safety inspectors found the infantis strain in packaged chicken breasts, sausages, and wings during routine inspections at poultry plants.

FDA’s Proposed Global Regulatory Harmonization for Medical Devices

On February 23, 2022, the Food and Drug Administration (FDA) published a proposed regulation to amend current manufacturing practice requirements of the Quality System Regulation (QSR) (21 CFR Part 820). The FDA first announced such harmonization in 2018, however COVID-19 delayed the proposal. The FDA seeks to align Part 820 more closely with the international specific standard for medical device quality management systems set out by the International Organization for Standardizations (ISO) 13485. According to the FDA, such “harmonization should provide patients more efficient access to necessary devices, leading to improvements of life quality of the consumers.” Part 820 is part of the current mandatory regulations that ensure that all medical devices created and developed within the US market are safe. ISO 13485 is the international standard for a quality management system for medical devices required by certain countries. Therefore, any manufacturer that sells outside the US will likely need to be ISO 13485 certified. With the implementation of this new amendment, manufacturers would be able to assure their products are regulatorily compliant in both the US and international markets.

What’s the Tea?

When people hear the phrase “regulatory compliance”, they often think about the finance, banking, or tech industry – not the business of loose and pressed leaves. In fact, the tea industry has been on the rise and is projected to reach almost $69 billion by 2027. Within that market, the green tea segment is the highest growth contributor with an estimated $16 billion in 2019 and is projected to reach almost $26 billion by 2027. This leafy market comes with its own set of compliance issues and a potential for growth this year.

Compliance and Aducanumab – How Should Providers Balance FDA and CMS Guidance?

As my colleague at Inside Compliance discussed here in September, the FDA approved Aducanumab for the treatment of Alzheimer’s Disease on June 7, 2021. Aducanumab, marketed as Aduhelm, is intended to reduce beta-amyloid levels. This compound is responsible for forming a “plaque” which inhibits neuron function and eventually triggers neuronal apoptosis (death of neurons). Now, a recent decision by CMS on insurance reimbursement for aducanumab has increased the compliance responsibilities of providers.

FDA-USPTO Collaboration and Bipartisan Efforts to Lower Drug Prices

The Food and Drug Administration (FDA) has partnered with the Patent and Trademark Office (USPTO) to address the high cost of prescription drugs. While the FDA possesses the authority to approve generic, lower cost drugs, the USPTO has an important and symbiotic role in bringing affordable drugs to market by blocking anti-competitive patent extensions. FDA-USPTO collaboration has gained congressional support and is the subject of key pieces of new legislation.