Emerging Trends in Medicine

Direct-to-Consumer Marketing: 20 Years Later Direct-to-consumer (“DTC”) advertising of prescription drugs and devices by pharmaceutical companies has been in effect for almost 20 years. In addition to the billions spent in marketing directly to physicians, pharmaceutical companies spend billions of dollars per year (5 billion in 2015), to tell patients and potential patients why they

Drug Administration (FDA) required that advertisements provide a detailed list of potential side effects to consumers. DTC advertising most commonly appears on television, internet websites, radio, and print – magazines, brochures, billboards, newspapers. Ads generally fall into three categories: • “Product-claim” – specific name and claim – i.e., Viagra, Humira.

Paul Giancola, Esq. should take certain drugs. In 2015, one quarter of the money spent was to advertise only five drugs. (I’m sure you can name them). Not surprisingly, the most advertised drugs are heavily prescribed and reap the biggest profits. DTC advertising of drugs became legal in the United States in 1985. However, until 1997, the U.S. Food and 10 AZMedicine | Fall 2016

• “Help-seeking” – do not recommend a specific drug, but discuss disease or condition, such as allergies, diabetes, asthma, osteoporosis, and high cholesterol. The ad usually includes the name of the company, and encourages the consumer to talk to their doctor. • “Reminders” – give the name of the drug, and assumes the audience – physicians and consumers – are already aware of the drug’s use. Over the years, the debate about DTC advertising has largely focused on whether it provides useful information to consumers, resulting in better

Not surprisingly, the most advertised drugs are heavily prescribed and reap the biggest profits. health outcomes due to disease awareness, or if it encourages expensive overuse of the costliest drugs. At one end of the spectrum, physician’s organizations, such as the American College of Physicians (APA), believe that DTC advertising is inappropriate and undermines the physician – patient relationship leaving patients confused and misinformed about drugs.1 Recognizing that DTC is here to stay, the APA and the American Medical Association (AMA) encourage physicians to take an active and critical role in ensuring that DTC ads improve the communication of health information and contain accurate information on risks, benefits, and costs.2

FDA Regulation The FDA has the authority to

regulate “product claim” ads. Such ads must present a drug’s benefits and risks in a balanced fashion, and should not be false or misleading. Print ads must also include a “brief summary” about the drug that includes the risks listed in the prescribing information. Broadcast ads, however, must only address the drug’s most important risk (“major statement”) and either provide all the risks listed in the prescribing information or a variety of sources for viewers to find the prescribing information for the drug. Such sources may include a doctor, website, toll-free number, or magazine print ad. Help-seeking ads are not generally regulated, as they are not considered drug ads. However, the FDA does regulate them if they suggest

or recommend a specific drug. Similarly, reminder ads are not regulated, unless they offer drugs with serious risks, such as those with a boxed warning, or if the ad provides or suggests information about the drug’s risks and benefits.

State Regulation and Sunshine Act The FDA regulates national advertising. Because of the FDA, there is little legislative space for states to address DTC. A few states, however, have laws that address DTC advertising, marketing, and doctor detailing. Such state laws typically contain disclosure and reporting requirements. However, with the passage of the “Sunshine Rule” or “Open Payments” rule, pharmaceutical companies now must report payments or other transfers of value to physicians for drugs and devices covered by Medicare and Medicaid.

Impact on Patient Care Surveys of physicians cited by the FDA 3 indicate that patients who saw DTC ads asked thoughtful questions, were more involved in their healthcare, and had better discussions with their doctors. Physicians, however, did not believe that such ads conveyed information about risks and benefits equally well. Nevertheless, according to the FDA, only eight percent of physicians felt “very pressured” to prescribe a specific brand-name drug when asked. However, in other surveys,

Surveys of physicians cited by the FDA indicate that patients who saw DTC ads asked thoughtful questions, were more involved in their healthcare, and had better discussions with their doctors. physicians have reported that advertising induced demand made them more likely to prescribe the brand-name drug requested.4

Physician Obligations The AMA Ethics Opinion states that: • Physicians must maintain professional standards of care when prescribing; • Physicians should engage in a dialogue to assess the patient’s understanding of the treatment; • Physicians should not be biased against advertised drugs; • Physicians should resist commercially induced pressure to prescribe drugs that may not be indicated; • Physicians should deny requests for inappropriate prescriptions, and should educate patients as to why, and the different treatment options;

• Physicians should be vigilant to ensure that DTC does not promote false expectations, and to consider reporting such DTCs that do not follow the applicable FDA regulations.

being prepared to discuss evidenced-based studies on the benefits and risks of such drugs. Physicians must, however, always remain vigilant to only prescribe drugs that are medically indicated for a patient regardless of the pressure brought to bear on their medical judgment by patients and advertisements. AM Paul J. Giancola, JD, is a partner in the Healthcare Practice Group, Snell & Wilmer, LLP, Phoenix, Arizona. 1

See, Direct-to-consumer prescription drug advertising, American College of Physicians, a position paper (2006).

2

Id. AMA opinion 5.015 – Directto-Consumer Advertisements of Prescription Drugs, AMA Code of Ethics (1998).

3

See, FDA. The Impact of Direct-to-Consumer Advertising, Information for Consumers, UCM 143562, Oct. 23, 2015. http:// www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143562. htm

4

See, Gellad & Lyles, The Impact of Direct-to-Consumer Advertising of Pharmaceuticals, Am. J. Med. 2007, Jun; 120(6), 475-480.

Summary DTC of drugs are now as common as beer and car commercials. However, in contrast to beer and cars, a prescription from my physician is required to obtain a DTC product. DTC advertising is without question both successful and profitable. This means that pharmaceutical companies will continue to increase DTC to both stimulate demand and profits for their drugs. Physicians, however, are ethically required to remain objective patient advocates. Accordingly, physicians should be educated and prepared to discuss the pros and cons of specific drugs, particularly those that are powerfully advertised. This may include

Summer 2016 | AZMedicine 11

Direct-to-Consumer Marketing: 20 Years Later - Snell & Wilmer

Nov 9, 2016 - health outcomes due to disease awareness, or if ... FDA Regulation. The FDA has ... have laws that address DTC ... healthcare, and had better.

524KB Sizes 0 Downloads 190 Views

Recommend Documents

Direct-to-Consumer Marketing: 20 Years Later - Snell & Wilmer
Nov 9, 2016 - can name them). Not surpris- ingly, the most advertised drugs are heavily prescribed and reap the biggest profits. DTC advertising of drugs.

Direct-to-Consumer Marketing: 20 Years Later - Snell & Wilmer
Nov 9, 2016 - States in 1985. However, until 1997 ... provide a detailed list of poten- tial side effects to .... cal judgment by patients and advertisements. AM.

Snell&Wilmer
Sep 19, 2016 - service mark is the same as a trademark, but distinguishes services instead of goods. Trade dress is .... trademark cancellations and domain name disputes; and preparing manufacturing, consulting and technology contracts.

Snell&Wilmer
Sep 19, 2016 - Best to select a unique mark that is either an invented word with no meaning ... obtain state registration, regardless of the area of geographical use in the state. ... the mark and buy products based on the quality/reputation associat

Snell&Wilmer - JD Supra
Nov 15, 2016 - Many businesses ... internet searching software would likely be found to conflict with “Google.” III. ... banking or insurance, the records of the appropriate agency responsible for registering such names should be searched and.

Cybersecurity - Snell & Wilmer
Sep 30, 2016 - 25% of all of the data breaches that we hear about and ... when there is a data breach or cyber. DANIELLE ... no matter how small or large, can.

November 2016 - Snell & Wilmer
Nov 22, 2016 - the beneficent author of all the good that was, that is, or that will be; that ... such a degree of temporal prosperity as He alone knows to be best.

PRESS RELEASE - Snell & Wilmer
Jan 18, 2017 - Adobe. RealSource. Price-CCIM Scholarship. Katie Wilking Clinard ... that requires 100+ hours of training and considerable investment. Learn.

Snell&Wilmer - JD Supra
Nov 15, 2016 - “apple pie a la mode” is descriptive or generic of apple pie with ice cream. But, its acronym, “APALM,” would likely be considered a fanciful, ...

September 2017 - Snell & Wilmer
Sep 12, 2017 - (Cleaned up). Litigation—Slander ... App.5th 603 (2017), held that a plaintiff must make a ... in the amount of $1,000, plus costs and “including.

IP Stars - Snell & Wilmer
May 30, 2017 - In addition, he has worked with a number of technology clients to develop ... Throughout his career, Langton has prepared and prosecuted U.S. and foreign patent applications and handled large patent ... For more information,.

IP Stars - Snell & Wilmer
PHOENIX (May 30, 2017) – Snell & Wilmer is pleased to announce that for the third ... hardware, internet, business methods, solar tracking, financial services, ...

IP Stars - Snell & Wilmer
Jun 22, 2016 - biotechnical, mechanical, electromechanical, computer software, medical ... de-facto Chief Patent Counsel for several Fortune 500 companies. ... subterranean drilling, all aspects of automobile technology, semiconductor and ...

Ranking Arizona - Snell & Wilmer
Apr 17, 2017 - ... business leaders throughout Arizona, participated in an online opinion poll ... company's revenue and number of employees. About Snell & Wilmer. Founded in 1938, Snell & Wilmer is a full-service business law firm with ...

September 2017 - Snell & Wilmer
5 days ago - who created the writing or the law firm that employs the attorney? In Tucker Ellis LLP v. Superior Court, 12. Cal.App.5th 1233, 220 Cal.Rptr.3d ...

PRESS RELEASE - Snell & Wilmer
Salt Lake City, UT–March 6, 2017–The Utah Chapter of CCIM honored 16 individuals at its 2017. Excellence Awards event. Held at the Grand America Hotel on ...

Cybersecurity - Snell & Wilmer
Sep 30, 2016 - the last ten or fifteen years. Let's start ... and social engineering. To level set the ... it will help harden your networks ... (UAT) into a unique all-STEM institution that marries the best ..... part of larger systematic campaign.

September 2016 - Snell & Wilmer
Sep 27, 2016 - about my role in building an excellent Education Law practice and continuing to serve so many clients who work day in and day out to improve ...

Snell&Wilmer - JD Supra
Nov 15, 2016 - “apple pie a la mode” is descriptive or generic of apple pie with ice cream. But, its acronym, “APALM,” would likely be considered a fanciful, ...

by lmg - Snell & Wilmer
SNELL & WILMER PARTNER DANIEL S. WITTENBERG NAMED “LIFE SCIENCES STAR” BY LMG. DENVER (September 6, 2016) – Snell & Wilmer is pleased ...

IP Stars - Snell & Wilmer
Jun 22, 2016 - the technology, telecommunications, energy and pharmaceutical ... career, Grant has prepared and prosecuted U.S. and foreign patent ...

Snell&Wilmer - JD Supra
Sep 19, 2016 - your business or project to you; (b) require a written disclosure to you of .... Failing to Claim Larger Devices or Systems in Which the Invention ...

Partner Spotlight - Snell & Wilmer
Jun 23, 2016 - Email questions and reports to [email protected]. 1 ... rolled out our asset management platform .... his or her best abilities.

Partner Spotlight - Snell & Wilmer
Jun 23, 2016 - Email questions and reports to [email protected]. 1. It's a time of graduations, ... service contracts, caulking, etc., to name just a few typical items ... and JV boys basketball. Congrats to Skyline and keep up the good.