At the spring 2025 Pharmaceutical Compliance Congress (PCC) event in McLean, Virginia, speakers had many best practice tips and lessons learned to share with attendees, but they also pointed to several recent settlement actions, executive orders and state-led initiatives that were setting the tone for healthcare regulation in 2025 and beyond.

Let’s take a peek.

Gilead settles for $177m

Since the conference was in full swing when a settlement action involving biopharmaceutical company Gilead was announced on April 29, it was a topic that prompted ample discussion.

In the settlement action, Gilead agreed to pay $202m to the Justice Department and some states to resolve claims it made improper payments to high-volume prescribers of its HIV drugs, New York prosecutors said.

The US Attorney’s Office for the Southern District of New York (SDNY) said the company will pay nearly $177m to the federal government – plus about $25m to several states – to settle claims that it paid millions to doctors in the form of speaking fees, dinners and other perks as a reward for being high prescribers of its HIV drugs or to encourage them to prescribe those drugs. 

As a result of its misconduct, prosecutors argued, federal healthcare programs paid millions of dollars in reimbursements for “tainted prescriptions.”

This lawsuit and settlement was a qui tam whistleblower action in which the government joined the private whistleblower lawsuit that had been filed under seal pursuant to the False Claims Act (FCA).

Kickbacks at Gilead

In the case, a whistleblower alleged in 2016 that Gilead violated the FCA and the Anti-Kickback Statute by paying doctors to prescribe the HIV drugs Stribild, Genvoya, Complera, Odefsey, Descovy and Biktarvy. As the government’s press release notes, these drugs are very expensive – Medicare typically pays well in excess of a thousand dollars for a one-month supply of Complera, and significantly more for many of the other Gilead HIV Drugs.

Prosecutors alleged that as a part of Gilead’s marketing efforts and to increase sales, Gilead conducted events known as “HIV Speaker Programs” at which a healthcare provider involved in the treatment of HIV was engaged to present a slide deck (prepared by Gilead) and facilitate discussion about one of the drugs or a topic concerning HIV to other healthcare providers involved in the treatment of HIV.  Gilead’s HIV Speaker Programs were often held in the evening at restaurants (“HIV Dinner Programs”) to promote and increase the sales of the Gilead HIV Drugs. 

The HIV Speaker Programs were supposed to be educational in nature and the cost of any meals provided was supposed to be modest. 

But in practice, prosecutors alleged, Gilead’s HIV Speaker Programs provided kickbacks to healthcare providers by holding HIV Dinner Programs at high-end restaurants that were “inappropriate for educational events”; allowing Attendees to attend HIV Dinner Programs on the exact same topic again and again and, thus, “obtain free lavish meals for events that held minimal educational value for them.”

The company also often paid for HIV Speakers to travel to speak at desirable destinations, at times at the HIV Speaker’s request, prosecutors said.

According to the agreement, Gilead agreed to cooperate with the government’s ongoing investigation of individuals and other entities not subject to the settlement. 

Jay Clayton, the United States Attorney for SDNY (and a former chairman of the SEC) said: “With this settlement, Gilead has taken responsibility for its conduct and agreed to pay a significant financial penalty. The message is clear, companies that illegally drain taxpayer dollars from federal healthcare programs will be held accountable.”

Drug-pricing executive order

On April 15, 2025, President Trump issued an Executive Order instructing federal agencies to implement a variety of drug pricing reforms. The Executive Order addresses drug pricing from several different angles, including pharmacy benefit manager (PBM) competition and transparency, Medicare and Medicaid drug pricing, and international importation issues, among other things.

The Executive Order directs the Secretary of Health and Human Services (HHS) to propose and seek comment on guidance for the Medicare Drug Price Negotiation Program to improve the transparency of the program, as the order states.

One area pharma executives are focused on is the Inflation Reduction Act’s (IRA’s) so-called “pill penalty,” in which small molecule drugs (typically in pill form) are eligible for price negotiation nine years after approval by the Food and Drug Administration (FDA), whereas biological products become eligible after 13 years.

The “pill penalty” has been the subject of ire for many manufacturers who have argued that it stifles innovation.

The Executive Order directs HHS to work with Congress to modify the Negotiation Program to align the treatment of small molecule prescription drugs with that of biological products.

Speakers at the PCC event were curious about where the Trump Administration would land on this one. Some seem to think what will happen is that the IRA will be kept in place alongside measures to improve the existing Negotiation Program to create a more level playing field among drugs.

AGs send letter to FDA

Earlier this year, the National Association of Attorneys General sent a letter on behalf of a bipartisan coalition of 38 state and territory attorneys general that calls on the FDA to take decisive action against the unlawful sale and distribution of counterfeit and illegally sold GLP-1 drugs, including Mounjaro, Zepbound, Ozempic, and Wegovy.

These medications, the AGs state, are in high demand for weight loss and diabetes management, and have become targets for bad actors seeking to profit from supply shortages and high costs.

They called on the FDA to use its broad jurisdiction and resources to lead the campaign against the dangerous adulteration of GLP-1 medications in the US drug supply and urged the FDA to exercise its statutory authority through investigations, inspections, and enforcement actions to safeguard consumers.

The “lead states” directing the action are Colorado, Illinois, South Carolina, and Tennessee.

Open Payments Program at CMS

At the PCC event, panelists from Purdue Pharma LP, Daiichi Sankyo Inc and the law firm King & Spalding LLP discussed the Open Payments Program at the US Centers for Medicare & Medicaid Services (CMS). The program is a national disclosure program that houses a publicly accessible database of payments that reporting entities, including drug and medical device companies, make to covered recipient.

Or, put another way, the program provides visibility into financial relationships between drug and medical device companies and physicians, physician assistants, advanced practice nurses, and teaching hospitals, obligating pharmaceutical and medical device companies to report to CMS the payments and other transfers of value for research, meals, travel, gifts, speaking fees, etc., they made to those medical professionals.

CMS makes this data available to the public, so anyone can search for health care providers and see the payments they received, when they received them, and the companies that made the payments.

Speakers said the main sticking points with regard to this reporting were:

• protecting the privacy and integrity of the data, which is often at least partly (if not mostly) full of sensitive, personal details, in a manner that complies with US state and EU privacy laws;
• being able to produce this data if it is subject to a Freedom of Information Act or is discoverable in a legal action;
• having the time and staffing to produce and report on the many pieces of data, which often involves hiring outside counsel to evaluate and locate the data and engage with auditors from CMS, which conducts such audits with each covered business every three to five years.

The panelists stressed that, as time-consuming as the transparency reporting was for their businesses, going through the reporting and audit processes helped improve their compliance programs overall.