Summarise the rules relating to advertising and promotion of medicinal products and medical devices, explaining when the provision of information will be treated as promotional. Do special rules apply to online advertising?
For prescription drugs and restricted devices (those subject to restrictions via regulation or Food and Drug Administration (FDA) approval due to risk), the Federal Food, Drug, and Cosmetic Act is the primary source of the FDA’s authority over promotion via labelling (promotional materials) or advertising (print or broadcast), whether to payers, physicians or direct-to-consumer (DTC). The Federal Trade Commission (FTC) has a subsidiary role, but can still police certain aspects of advertising by prescription drug manufacturers. However, the FTC has primary jurisdiction over monograph over-the-counter drug and non-restricted device advertising. State laws also have a role, to the extent they are not pre-empted by the federal framework. There are also private rights of action for addressing competitor disputes, including under the Lanham Act. In addition, the False Claims Act provides for ‘relator’ actions seeking to recoup government payments for false claims induced by marketing or other violations, with a ‘bounty’ for the relator filing the case. Industry associations also maintain codes of conduct focused on pharmaceutical marketing and sales, including payments to physicians.
There is a wide array of requirements for such advertising, including for prescription drugs, routine submission of promotional materials to the FDA (and in limited scenarios, pre-clearance) and:
- avoiding any claims that are false or misleading, including by implication or depiction;
- not making claims beyond the approved indications and labelling; although such restrictions are now under scrutiny and somewhat relaxed due to recent First Amendment case law recognising pharmaceutical free speech rights pertaining to communication of off-label truthful and non-misleading information;
- ensuring appropriate support for product claims, including comparisons and claims of superiority;
- adequately communicating safety information and balancing the presentation of the benefits and risks generally; and
- providing contact information to enable the provision of full labelling, responses to questions and reporting of adverse events.
Similar rules apply to DTC advertising, but there is more of an emphasis on the appropriateness of claims, balance (including in visual representations), providing extensive and prominent safety information and providing methods to obtain the full labelling. The FDA has also issued guidance on the application of the above principles in the context of the internet, and social media particularly, providing information on when such information is attributed to the manufacturer, how required risk information can be conveyed in character-limited social media such as Twitter, and how companies can seek to correct misinformation in social media. Finally, the pharmaceutical and medical device trade associations maintain codes of conduct relating to DTC advertising.
Not all communications by manufacturers are subject to such restrictions and requirements. Communications that are not promotional (eg, investor communications and bona fide scientific exchanges (such as responding to a physician’s unsolicited questions)) are not within the FDA’s jurisdiction. However, certain communications, such as press releases, may have investor, scientific and promotional audiences, depending on how they are utilised. Companies typically maintain review processes and compliance controls to delineate between such types of communications in a consistent and compliant manner.Inducement
What regulations exist to discourage the provision of inducements to healthcare professionals to prescribe, sell, supply or recommend use of a particular medicinal product or medical device?
The primary authority governing such inducements is the Anti-Kickback Statute (AKS), which prevents ‘kickbacks’ to providers that could influence the practice of medicine and prescribing. However, it is a very wide-ranging and ambiguous statute, and thus, relationships with providers and institutions that submit claims to payers, particularly federal healthcare programmes, need to be examined carefully and should be well documented in agreements based on unclear [is ‘unclear’ correct?] ‘safe harbours’ developed over years of interpretation and advisory opinions. The setting of care and relevant payment frameworks will have an impact on such analyses. The AKS is a criminal statute, and it is administered by the Department of Health and Human Services Office of Inspector General and the Department of Justice. In addition to the AKS, which is intended to prevent undue remuneration to physicians that induce prescribing in the US, transfers of value to physicians and institutions outside of the US may come under scrutiny under the Foreign Corrupt Practices Act (FCPA). The FCPA prohibits bribery of foreign officials, including certain physicians and institutions affiliated with governments, and addresses accounting transparency requirements under the Securities Exchange Act of 1934. Companies typically maintain extensive compliance programmes to ensure adherence to these requirements, and ensure that all payments to healthcare practitioners and institutions are bona fide in nature and based on fair market value.Reporting transfers of value
What requirements apply to recording and publishing details of transfers of value to healthcare professionals and organisations by companies marketing medicinal products or medical devices?
Payments to US physicians and teaching hospitals (and, from 2022, to advance practice nurses and physician assistants as well) are subject to a reporting scheme under the Physician Payments Sunshine Act, under which such transfers of value – including indirect payments – by manufacturers are routinely reported and posted on a government-run ‘Open Payments’ website in considerable detail.
Enforcement of advertising rulesEnforcers
Describe the bodies involved in monitoring and ensuring compliance with advertising controls for medicinal products and medical devices, distinguishing between any self-regulatory framework and control by the authorities.
The Food and Drug Administration maintains three centres for regulating drug, biological and medical device products:
- the Center for Drug Evaluation and Research, which includes the Office of Prescription Drug Promotion, which regulates most drug and biological promotion;
- the Center for Biologics Evaluation and Research, which includes the Advertising and Promotional Labeling Branch, which regulates promotion of certain biological products, such as cell and gene therapies, blood products and vaccines; and
- the Center for Devices and Radiological Health, which maintains a similar function for device promotion.
These organisations develop guidance, review complaints, conduct surveillance on promotion (eg, at scientific meetings, in social media), review materials when submission is required and pursue enforcement when appropriate. The FTC’s Division of Advertising Practices has a primary role with respect to monograph over-the-counter (OTC) drug products and non-restricted medical device advertising.
While the primary trade associations in this area – such as PhRMA and AdvaMed – maintain various compliance codes, they do not operate self-regulatory systems for adjudicating promotional disputes. The National Advertising Division of the Better Business Bureau does maintain such mechanisms, but it is largely focused on consumer product claims, such as for OTC drugs and devices.Sanctions
What are the possible financial or other sanctions for breach of advertising and promotional controls for medicinal products or medical devices?
In most cases, agency findings relating to non-compliant promotion are the subject of an enforcement letter and remediation by the recipient. However, in cases of significant violations, the consequences can include civil and criminal penalties, imprisonment, exclusion from government healthcare programmes, including corporate integrity agreements, and liability under statutes such as the False Claims Act due to inducement of claims for government payment.
Pricing and reimbursementPricing
What are the controls imposed on pricing of medicines and medical devices and reimbursement by national social security systems that are applicable to manufacturers, distributors and pharmacists?
This varies greatly in the US. While there are complex systems governing issues such as providing best price and rebates on pricing in certain government programmes, and government programmes may consider data in coverage and reimbursement decisions, many such programmes are obligated to pay for all covered drugs, while controlling use via formulary reviews, tiering and other mechanisms. Some, particularly in the device area, may utilise health technology assessment processes. In commercially run insurance programmes, consideration of cost-effectiveness and associated analyses has become routine, and various formulary and other mechanisms are used to control use accordingly. A particular current focus is the development of value-based arrangements with payers, in which the manufacturer and payer share risk, and payment is based on product performance in the relevant patient population. The Affordable Care Act remains under legal challenge by the Trump administration, which could impact the entire US healthcare system, and Congress has been considering various proposals for reforming drug pricing in the United States. At this juncture, any significant changes will likely be under a future administration.
Sale and supplyRegulation
Are there special rules governing the dispensing or sale of particular types of medicinal products or medical devices?
Beyond general prescription status, drug products may be subject to special restrictions, known as Risk Evaluation and Mitigation Strategies, that may – to maintain the benefit-risk balance for the product – require adherence to various controls over prescribing, dispensing and patient access, including registries, training and agreements. Controlled substances are also subject to special restrictions at both the federal and state level, which may vary depending on how they are scheduled by the Drug Enforcement Administration. Medical devices may also be made subject to certain dispensing or sale restrictions or conditions of use as part of approval.Online supply
What laws and guidelines govern online dispensing, sale and supply of medicinal products and medical devices?
Drug and device products dispensed online are not exempt from the general rules relating to prescribing prescription products, and such products must be subject to appropriate regulatory approvals and clearances. Foreign online pharmacies may not ship drug products into the United States. Various federal and state laws apply to online pharmacies and suppliers, including associated telemedicine functions, such as a federal prohibition on the prescribing of controlled substances online, and a wide array of rules at the state level relating to valid prescriptions, licensing, practice of pharmacy, reciprocity among jurisdictions, and other areas.