U.S. Rep Introduces Bill to Limit Drug Advertising

February 25, 2016--A Connecticut representative has introduced a bill that would restrict direct-to-consumer advertising by pharmaceutical companies. Rosa DeLauro, a Democrat representing Connecticut’s third Congressional district, has introduced the “Responsibility in Drug Advertising Act,” which would require a delay of three years on any advertising of newly approved prescription drugs. 

Direct advertising to consumers by pharmaceutical companies has also been opposed by Democratic presidential hopeful Hillary Clinton and by the American Medical Association (AMA).

“At the end of the day, we should allow informed medical professionals, not advertising executives, to guide our healthcare spending,” said DeLauro in an official announcement of the bill. 

The Congresswoman added that the moratorium on advertising would minimize the perpetuation of inaccurate drug information and control costs by limiting the number of drugs that consumers can ask their physicians about directly, thereby putting more control in doctors’ hands to determine treatment options. DeLauro cited a 13% increase in prescription drug spending in 2015 to $374 billion.

The legislation would also bar ads from running after the three-year delay if the Department of Health and Human Services determines a new drug comes with “significant” side effects.

However, there has been fervent disapproval of the bill. “What [Ms. DeLauro] is saying is that if you come up with a drug that is lifesaving, you could not tell people about it for two or three years,” said Dan Jaffe, the top lobbyist for the Association of National Advertisers, in a statement to Advertising Age. 

“Cutting people off from truthful, valuable and lifesaving information is not only deceptive but unconstitutional.” Jaffe added that the ban “would paternalistically roll the clock back decades to the days when only doctors could be ‘trusted’ to receive information about important health issues.”

DeLauro’s proposed legislation is the most recent major development in an ongoing debate over the appropriateness of direct-to-consumer drug advertising. 

At the Interim Meeting of the AMA in Atlanta in November 2015, a majority of attendees voted to back a total ban on direct-to-consumer advertising and called on Congress to prohibit the practice. They stated that drug ads geared towards consumers drives demand for expensive treatments when more affordable alternatives are available.

“Today’s vote in support of an advertising ban reflects concerns among physicians about the negative impact of commercially-driven promotions, and the role that marketing costs play in fueling escalating drug prices,” said AMA Board Chair-elect Patrice A. Harris, M.D., M.A., at the Interim Meeting. 

“Direct-to-consumer advertising also inflates demand for new and more expensive drugs, even when these drugs may not be appropriate.”

On the presidential campaign trail, Hillary Clinton has stated that, in an effort to lower drug expenses, she, if elected, would not allow pharmaceutical companies to deduct their direct-to-consumer advertising costs, and would require them to invest in deeper R&D rather than marketing strategy in exchange for taxpayer support.

Before the mid-1980s, pharmaceutical companies could only advertise their products to healthcare professionals. That practice changed when the FDA approved direct-to-consumer advertising, though the agency continues to regulate ads to confirm they are not misleading. To this day, only the United States and New Zealand allow for pharmaceutical companies to advertise directly to consumers.

RxforAmericanHealth publisher supports Task Force on Lowering prices, calls for additional Congressional leadership

Publisher's note:  The following is a copy of a letter sent today (January 12, 2016) by RxforAmericanHelath Publisher Daniel Hines to members of the Democrat Task Force designed to lower prescription drug prices.  In the letter, we support the intent of the Task Force, but urge them to expand their scope from the spike in generic drug prices to more comprehensive, bi-partisan legislation that will address the 'public (and Congress) be damned attitude of Pharma as it continues to charge whatever it wishes for medicines. This is the launch of what we believe will be a 'watershed year' that could finally end the pricing abuse of pharma,  with Congressional action that recognizes that a medicine that is unaffordable is, in and of itself, unavailable.  As many have noted, a medicine that is denied is of no health benefit. The letter follows:

I am writing in my capacity as publisher of the TodaysSeniorsNetwork group of nationally followed and read blogs,  including RxforAmericanHealth, to support your of  Congressional efforts with the formation of the Affordable Drug Pricing Task Force to lower prescription medicine prices for Americans.

It is time for Congress to pass comprehensive, bi-partisan legislation that will direct the Food and Drug Administration to act in a manner to facilitate access to safe, affordable medicines for Americans and to end the pricing abuses we continue to witness from Pharma in complete disregard of criticism from policy-makers the media and, yes, even Congress. This is a leading issue of the 2016 elections , and can be expected to grow in importance, as increasing numbers of Americans face the reality that a medicine that is unaffordable is, in and of itself, unavailable. 

I am a supporter of personal importation of safe, affordable brand-name prescription medicines from licensed, registered pharmacies in Tier One Countries whose standards of safety and efficacy meet or exceed those of the U.S.  However, I, and a growing number of Americans, realize that rather than a reliance upon a single solution, what is needed is a comprehensive approach to lowering prescription medicine prices.  This includes:

1.  Price negotiation;

2.  A ‘stakeholder’ role for the American public that supports so much of Pharma R&D,by an increased presence of consumer advocates and private citizen in policy development, hearings, and opportunities for public comment;

3.  A  revised patent policy that ensures the public investment in R&D is protected in legislation that will provide penalties if Pharma is abusive in its pricing practices;

4.  Reciprocal Memorandums of Understanding between regulatory agencies of Tier One Countries as validation of the safety and efficacy of the oversight of personally imported medicines from those countries;

5.  Criminal penalties for abuse of pricing practices based on a ‘what the traffic will bear’ philosophy;

6.  Greater transparency in Pharma pricing practices;

7.  An end to direct to consumer advertising for prescription medicines.

I am including links to three articles I hope you and your staff will find helpful.  I am sending this to your office via fax so you shall have a ‘hard copy’ for your consideration,.  I am also emailing it to your healthcare legislative aide. 

1. RxforAmericanHealth publisher calls for bi-partisan Consensus, Coalition legislation in Congress To lower prescription costs...The publisher of Rx for American Health is calling for a coalition of Senators and Representatives and their staffs to reach consensus on a single comprehensive bill incorporating major points of a number of disparate legislative proposals to lower prescription medicine prices, and to be prepared to offer their bill immediately with the reconvening of the  114th Congress in January 2016…

2    Why High Drug Prices require an Rx Bill of Rights for Americans…The publisher of RxforAmericanHealth has called for both the Democrats and Republicans to address the issue the impact of rising prescription drug costs by incorporating into their Party platforms an American Rx Bill of Rights…(continue) Time for A Congressional Caucus to support Congress moves on Personal Importation…

3.  The publisher of RxforAmericanHealth says that it is time for Congress to form a Congressional Caucus to support recently introduced legislative proposals on behalf of the personal importation of safe, affordable prescription medicines, and to act as a watchdog to prevent the potential of abuse by the Food and Drug Administration of Section 708 of the Food and Drug Administration Safety Innovation Act (FDASIA) with the unwarranted destruction of valid, safe medicines personally imported by Americans…(continue)

Thank you for taking the time to review these materials.  I shall look forward to your response.  If you have any questions, please feel free to contact me at the contact information listed at the top of this letter.
Daniel Hines

AMA Calls for Ban on Direct-to-Consumer Advertising of Prescription Drugs and Medical Devices

November 17, 2015 - Responding to the billions of advertising dollars being spent to promote prescription products, physicians at the Interim Meeting of the American Medical Association (AMA) today adopted new policy aimed at driving solutions to make prescription drugs more affordable. Physicians cited concerns that a growing proliferation of ads is driving demand for expensive treatments despite the clinical effectiveness of less costly alternatives.

"Today's vote in support of an advertising ban reflects concerns among physicians about the negative impact of commercially-driven promotions, and the role that marketing costs play in fueling escalating drug prices," said AMA Board Chair-elect Patrice A. Harris, M.D., M.A. "Direct-to-consumer advertising also inflates demand for new and more expensive drugs, even when these drugs may not be appropriate."

The United States and New Zealand are the only two countries in the world that allow direct-to-consumer advertising of prescription drugs. Advertising dollars spent by drug makers have increased by 30 percent in the last two years to $4.5 billion, according to the market research firm Kantar Media.

New AMA policy also calls for convening a physician task force and launching an advocacy campaign to promote prescription drug affordability by demanding choice and competition in the pharmaceutical industry, and greater transparency in prescription drug prices and costs.

"Physicians strive to provide the best possible care to their patients, but increases in drug prices can impact the ability of physicians to offer their patients the best drug treatments," said Dr. Harris.

"Patient care can be compromised and delayed when prescription drugs are unaffordable and subject to coverage limitations by the patient's health plan. In a worst-case scenario, patients forego necessary treatments when drugs are too expensive."

New AMA policy responds to deepened concerns that anticompetitive behavior in a consolidated pharmaceutical marketplace has the potential to increase drug prices. The AMA will encourage actions by federal regulators to limit anticompetitive behavior by pharmaceutical companies attempting to reduce competition from generic manufacturers through manipulation of patent protections and abuse of regulatory exclusivity incentives.

The AMA will also monitor pharmaceutical company mergers and acquisitions, as well as the impact of such actions on drug prices. Patent reform is a key area for encouraging greater market-based competition and new AMA policy will support an appropriate balance between incentives for innovation on the one hand and efforts to reduce regulatory and statutory barriers to competition as part of the patent system.

Last month, the Kaiser Family Foundation released a report saying that a high cost of prescription drugs remains the public's top health care priority. In the past few years, prices on generic and brand-name prescription drugs have steadily risen and experienced a 4.7 percent spike in 2015, according to the Altarum Institute Center for Sustainable Health Spending.

The AMA's new policy recognizes that the promotion of transparency in prescription drug pricing and costs will help patients, physicians and other stakeholders understand how drug manufacturers set prices. If there is greater understanding of the factors that contribute to prescription drug pricing, including the research, development, manufacturing, marketing and advertising costs borne by pharmaceutical companies, then the marketplace can react appropriately.

About the AMA
The American Medical Association is the premier national organization dedicated to empowering the nation's physicians to continually provide safer, higher quality, and more efficient care to patients and communities. For more than 165 years the AMA has been unwavering in its commitment to using its unique position and knowledge to shape a healthier future for America. For more information, visit ama-assn.org.