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Role drift and clinical trials among many areas for compliance professionals to keep an eye on in 2022.
Informa’s Pharmaceutical Compliance Congress (held in-person April 25-27, and virtually May 3-5), provided well-needed insights and reminders that risk never sleeps. Here are some top areas for compliance professionals to keep watch over in 2022. For more information on transparency and aggregate spend, please visit Informa’s August event.
Speaker Programs. Speaker programs are an area of DOJ scrutiny and, historically, enforcement because pharma has a lengthy history of violating anti-kickback statutes involved with their conduct and choices. With all the data involved in pharma, as well as the data accessible to prosecutors, said members of the key enforcement panel, compliance professionals also should be looking at the data at their companies. Questions that could potentially cause scrutiny include “Why do certain physicians get invited to 10 meetings a year?” “Where is your meeting being held?” And two other questions that involved a bit of audience consternation included: “Why is your meeting being held in-person vs. virtually?” and “Why do need to collect physician prescription data?”
Panel members assured that “bona fide efforts to educate HCPs” is not their concern. In the era of post-COVID, however, virtual meetings should not go away, but the choice as to why should be made clear. Audience members posed that they were in person because it is a more beneficial human interaction. The truth is, as another panelist mentioned, bad can happen virtually or in-person.
On the note of collecting physician prescribing data, some audience members responded that the data are collected to evaluate the company’s marketing efforts. And one further agreed that the data should not be used outside of that purpose for compliance reasons.
State Pricing Transparency. Currently, 18 states have requirements that pharma manufacturers provide notice when they intend to raise a drug price (wholesale acquisition cost or WAC) above a certain threshold or if they intend to launch a high-priced drug. There are additional requirements for each state, as well as additional states evaluating their own transparency laws. Many believe that states are taking control in lieu of any movement on the federal level. Meanwhile, many are convinced that any Democratic-initiated federal plan will not come to fruition in 2022, and potentially at all if the legislature controls change at the mid-terms. Regardless, for compliance purposes, keeping track of the many requirements is difficult and potentially costly. For example, John Oroho, Executive Vice President and Chief Strategy Officer at Porzio Life Sciences, noted that seven-figure penalties have been issued by the state of California for not reporting on time. Even if there is no change, some states still require a reporting deadline.
For more information on transparency and aggregate spend, please visit Informa’s August event.
Social Media. It may not always be as obvious as Khloe Kardashian and Biohaven Pharma getting called out for off-label statements around Nurtec made on Twitter. Many companies find and use influencers, but pharma also needs to look at their influencers global reach…what an influencer says in the United States can reach an audience regulated in a country that doesn’t allow any promotion for drugs. Dealing with the compliance around an influencer or social media in general requires clear parameters, and even those can be hard to control.
Role Drift. More and more compliance officers are unclear on new titles or roles and who has been hired to do what, which has been occurring more on the medical affairs and commercial side. One compliance officer stated that they need to know what the employee was hired to do, who they are talking to and what they are saying; and the employee also needs to be well within these guidelines. The best advice was for compliance to receive the new job description as well as the business plan around this role. Then, regardless of the title, the training can be in the appropriate bucket.
In addition, the need to have clear handoffs between the functions, especially in a hybrid environment should be examined.
Data privacy, compliance and safety. There needs to be a compliant function for data technology, where the data comes from, what it is being used for and how it is secure. The larger the company, the more technology means the increased risk. Compliance needs to know where all the data in the company is being held. Other questions to be asked, for example, are there regulations around SaMD, ethical AI, what do your EHR health alerts do, and what other increased digital health initiatives exist?
Clinical Trials. Statements made in December 2019 by the Deputy Assistant Attorney General Arun Rao identified clinical trial fraud as one of four key areas of enforcement focus by the Consumer Protection Branch of the DOJ, which warrants compliance attention. One panelist noted that the Consumer Protection Bureau is one that uses cutting edge data analysis to ferret out fraud, and that recent cases include single PI, single site fabricating subjects and subject data; CRC and investigator fabricating subjects and subject data in a group of related sites; and the highly risky situation of subjects that should have been excluded from a trial, receiving IMP.
All in all, experts recommend that pharma regularly check its “outlier” data coming from investigative sites for potential fraud (a CRO informing a pharma company of an outlier is how one case was uncovered); to routinely check participant addresses for their validity; and consider not conducting research in geographical areas that show up as non-compliant or higher risk in a heat map exercise. Ultimately, the question from the DOJ will come down to the pharma sponsor, regardless if the study was outsourced, “could you or should you have known of violation by looking at the data?”
Other Fraud Risks. Overall, there are other potential healthcare areas that the DOJ will be examining coming out of COVID.
Telehealth. Because of regulatory and insurance coverage changes around telehealth, the DOJ anticipates that fraudulent activity has occurred. One panelist noted, “We aren’t knocking telehealth and its' helpfulness, but it does carry a higher compliance burden. If it’s a big part of your business plan, make sure it’s compliant.”
COVID. There will be an expected uptick in direct COVID-related activities such as PPE or PPP grants; testing and vaccination fraud and people misusing COVID funds. Most of these will be criminal cases and will evolve as retrospective information comes to light.