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2026 Summer Newsletter
President's Report
As we move through the year, I’ve had the opportunity to work alongside an incredible group of volunteers who are committed to strengthening our chapter and creating meaningful value for our members.
Over the past several months, we’ve focused on revitalizing our Education and Sponsorship Committees. These groups have been working behind the scenes to identify educational opportunities, strengthen relationships with our sponsors, and lay the groundwork for future programming that is relevant, practical, and engaging.
This spring, we hosted our Spring Education Day, providing members with an opportunity to earn continuing education, exchange ideas, and connect with colleagues from across the state. We also introduced member appreciation and networking events to create additional opportunities for healthcare risk professionals to build relationships outside of the classroom. One of the greatest benefits of chapter membership is the opportunity to learn from one another, share experiences, and build a network of colleagues who understand the unique challenges of healthcare risk management.
Looking ahead, we’re excited for our Fall Education Day, which promises another day of quality education, professional development, and meaningful discussion. In addition to the educational program, we’re planning a fun social event afterward to give members an opportunity to unwind, continue the conversation, and strengthen the relationships that make our profession so collaborative. We hope you’ll join us for both the learning and the camaraderie!
While these are positive steps, there is still work to do. Professional organizations are strongest when members actively participate, not only by attending events, but by sharing ideas, volunteering, and helping shape the direction of the chapter. Your feedback and involvement are essential as we continue to grow and evolve.
Whether you’re interested in serving on a committee, presenting at an educational event, becoming a sponsor, or simply attending one of our networking events, I encourage you to get involved. Every member brings a unique perspective, and together we can continue building a chapter that supports, connects, and advances healthcare risk professionals across Alabama!
Thank you for your continued support of the AlaSHRM. I look forward to seeing many of you this fall and to continuing to build a strong community of healthcare risk professionals together!
Warm regards,
Sarah Bush, MBA, CPHRM, FASHRM
President, Alabama Society for Healthcare Risk Management
Sponsor Article
Compound Crackdown: The FDA Tightens up on Restrictions for Compounded Drug Ingredients and Advertisements
By Kaelin O’Reilly and Anne Marie Lyddy
In response to known risks about misuse, and unverified claims about quality, efficacy, and safety, the FDA is taking actions to impose more restrictions regarding non-approved and mass-marketed compounded medications, including certain GLP-1 products. The administration will address both usage of active ingredients in GLP-1s and the misleading advertising and marketing surrounding these drugs.
Restriction of Active Pharmaceutical Ingredients
Compounding pharmacies, which produce customized, low-cost versions of highly popular medications (like Wegovy), will now meet resistance from the FDA. This follows from a DOJ investigation after the launch of a compounded pill by the telehealth company Hims & Hers, which prompted a lawsuit by Wegovy manufacturer Novo Nordisk for intellectual property infringement and unlawful mass production of its product. As a result of the investigation, the FDA announced it would take steps to regulate the compounding of GLP-1 medications in the U.S. market and enforce restrictions on GLP-1 active pharmaceutical ingredients (APIs).
The FDA has warned consumers in the past about the potential risks of using compounded versions of FDA-approved medications. The raw materials used in the compounded versions do not require FDA approval or a premarket review for safety, effectiveness, and quality. The agency also warns that misuse or unnecessary use of non-FDA approved drugs can lead to serious patient harm, or even death. Reports to U.S. poison centers have shown an increase in medical issues related to compounded GLP-1 drugs, including overdoses and dosing errors, and the FDA identified instances of improper storage and inadequate refrigeration in shipments of these drugs, potentially compromising drug quality.
It is important to remember that not all compounding pharmacies are created equal. The FDA sees reports of marketing for counterfeit drugs, use of harmful or wrong ingredients, and illegal online sales. However, legitimate compounders work to fill gaps in the supply, providing versions of approved medications for consumers when the FDA-approved drugs are unavailable, or when patients need alternative forms of delivery (e.g., orally vs. intravenously) or more specific dosages. According to Janice Jin Hwang, clinician, and endocrinologist at the University of North Carolina at Chapel Hill, these legitimate pharmacies “have very good quality-control standards.”
The FDA’s compounding program “aims to protect patients from poor quality compounded drugs, while preserving access to lawfully marketed compounded drugs.” Earlier in 2025, the FDA released an import alert blocking potentially unsafe APIs—manufactured for the production of GLP-1 drugs—from entering the U.S. Market. The alert established a vetted “green list” of foreign manufacturers that passed safety and quality standards, and any APIs imported from sources outside that list (or those failing to meet FDA standards) are at risk of detention at the border. FDA Commissioner Marty Makary stated that the FDA will narrow the focus on importation of these unapproved APIs, likely by increasing inspections or border restrictions.
For those who fear limited access or resistance might prevent them from obtaining their weight-loss medications, a new government website, TrumpRx, allows patients to access partnered pharmaceutical manufacturers and direct-to-customer programs for certain eligible prescription drugs. These medications include GLP-1 medications like Wegovy (in both pen and pill form), Ozempic, and Zepbound, available at a lower cost through pricing agreements.
Unreliable Advertising Claims
On September 9, 2025, President Trump issued a memorandum calling on FDA Commissioner Makary and the U.S. Department of Health and Human Services (HHS) to begin efforts enforcing prescription drug advertising laws and regulations on compounded GLP-1 drugs. The FDA also announced that it would take steps to “rein in misleading direct-to-consumer pharmaceutical advertisements.” By the end of the quarter, the FDA issued over 40 warning letters and more than 100 cease-and-desist letters to compounding pharmacies and other related entities for deceptive, misleading, or inappropriate advertising practices related to compounded drugs. The warning letters cited four categories of inappropriate advertising claims around compounded drugs or compounded drug products.
The FDA warned pharmaceutical companies to comply with regulatory standards and that the administration would take enforcement actions to address these issues. The FDA specified that enforcement measures would include reviews of drug advertisements and implementation of artificial intelligence and tech-enabled tools for surveillance.
The Trump administration, including HHS Secretary Robert F. Kennedy, Jr., relayed that the primary goal of their efforts is to bring back transparency, accountability, and trust in healthcare, and to protect both patients and public health. The President’s memorandum emphasized a push for more truthful messaging in drug advertisements, with more comprehensive disclosure about safety and drug risks. He stated that the aim was to prevent these advertisements from compromising the doctor-patient relationship, from “promoting medication over lifestyle improvements,” and from pushing the more expensive versions of these medications without informing patients.
Further, the FDA criticizes the loophole created by the “adequate provision” requirement (1997), a provision requiring drug advertisements for TV and radio to direct consumers to separate sources for complete drug risks and safety facts. The loophole, the agency argues, enables pharmaceutical companies to downplay the risks of their product, overstate its benefits, and push the consumer to find the important safety information elsewhere. The FDA argues this shift is happening in digital and social media today with paid influencers blurring the line between evidence-based information and a desire to simply push products.
"Regulatory scrutiny of compounded GLP-1 products is intensifying,” said Anne Marie Lyddy, Senior Risk Management Consultant with ProAssurance, who weighed in on the regulations:
We are watching how evolving rules will redefine acceptable practices. The ongoing balance between innovation and compliance will continue to shape the risk for clinicians and patients. A proactive approach that is grounded in rigorous governance, meticulous documentation, and transparent patient communication will be critical to navigate the complexities going forward.
Sponsor Article
HERE WE GO AGAIN: Alabama’s Medical Malpractice Crisis
Alabama’s business and healthcare communities are again calling for tort reform, warning that without it the state’s economic growth and access to care will suffer.
The risk of practicing medicine in Alabama is increasing. While the number of claims has leveled off, the severity of claims, especially in medical malpractice cases, has risen sharply. According to the Alabama Department of Insurance, total payouts by 167 insurers increased from $9.6 million in 2020 to $23.5 million in 2024, a 140% increase.
Alabama has been here before. In the 1980s, rising verdicts, increasing court costs, and instability in the insurance market led to the passage of the Medical Liability Act of 1987. Today, many of the same pressures are resurfacing with different concerns such as; venue shopping, no cap on damages, large plaintiff attorney fees, widespread advertising by plaintiff lawyers, and a more negative public mindset toward healthcare following the COVID-19 pandemic.
The burden of this environment falls on healthcare providers across the state. Hospitals, physician practices, doctors, nurses, and other caregivers are increasingly drawn into costly litigation, even when the facts lean heavily toward the healthcare provider. These lawsuits carry emotional and financial consequences for the people who provide care, while also increasing malpractice premiums and encouraging defensive medicine. They also make it harder to recruit and retain healthcare professionals in Alabama, especially when all neighboring states have stronger tort reform protections in place.
Medical malpractice incidents are typically not the result of malicious conduct or recklessness, but rather unintended mistakes made by well-intentioned healthcare professionals performing demanding work in high-stress, high-risk environments. Most people agree that patients injured by proven negligence deserve fair and reasonable compensation. The concern arises when jury awards reach levels that far exceed what many would consider reasonable.
A significant turning point in Alabama’s law occurred in 1995, when the Alabama Supreme Court struck down the Alabama Medical Liability Act's $1 million cap on noneconomic damages in medical malpractice cases as unconstitutional. This decision eliminated a safeguard that remains common in many neighboring states and across the country, including jurisdictions with caps that are lower and less flexible than Alabama's original cap, which included provisions for inflation adjustments. Had it remained in effect, the cap would be worth approximately $2.5 million today. Such a limit would continue to provide meaningful compensation for injured patients that align with current economic factors.
However, without caps, awards have continued to climb and most recently at alarming rates. In March 2026, a Mobile County jury returned a $50 million verdict in a wrongful death medical malpractice case, up from a $35 million verdict in the same venue four years earlier. These outcomes reflect a troubling pattern of social inflation in jury awards and reinforce the perception that Alabama’s current system is out of balance.
The consequences extend well beyond the courtroom. Alabama tort costs total an estimated $6.4 billion annually, or about $3,286 per household, and the state ranks 13th nationally for tort costs as a share of GDP. These pressures affect healthcare, small businesses, and the state’s ability to compete economically.
Patients harmed by medical negligence deserve fair compensation. However, Alabama’s current litigation environment is producing excessive awards that strain the healthcare system, raise costs for families and employers, and make the state less competitive. A practical first step toward restoring balance would be for the Alabama Supreme Court to revisit the constitutionality of the damage caps and overturn the 1995 decision which would bring back reasonable limits on damages in medical malpractice cases once again.
