New PhRMA Policy: Not Everyone Satisfied

Regulation of Drug Advertising: A Short History

In 1906, with the passage of the Federal Food and Drugs Act, the Food and Drug Administration (FDA) gained its current name and added regulatory functions to its previous scientific mission. One of the matters the FDA attempted to regulate was false therapeutic claims made by “patent medicine” makers, but in the early days of the agency's forays into regulation of drug selling the courts were less than supportive. In 1911, the U.S. Supreme Court ruled that the 1906 law did not – contrary to the government's interpretation – apply to false therapeutic claims. An amendment in 1912 attempted to correct the law's language to allow better enforcement mechanisms for misbranding, but it required a showing of intent to defraud, a difficult standard for the agency to meet. Because of this, the FDA was powerless to protect the public from dangerous pharmaceutical products such as Banbar, a worthless “cure” for diabetes and Radithor, a radium-containing tonic that slowly and painfully killed its users, both of which the old law protected.

The agency and many in the public sector wanted the FDA to have more oversight authority over the drug industry, but a groundswell for change came only in 1937 when an untested medicine containing a chemical analogous to antifreeze was marketed for pediatric use and killed more than 100 people. The year following that disaster, and the public outcry that ensued, the Food, Drug and Cosmetics Act of 1938 was passed. It required drugs to be labeled with adequate directions for safe use and mandated pre-market approval of all new pharmaceutical products. While it also unequivocally prohibited false therapeutic claims for drugs, a separate law granted the Federal Trade Commission jurisdiction over drug advertising.

The Division of Drug Marketing, Advertising, and Communications (DDMAC) within FDA's Center for Drug Evaluation and Research (CDER) is now responsible for overseeing DTC advertising. Under the regulations, pharmaceutical companies are required to submit all drug advertisements to the FDA when they are first disseminated to the public, not before. It used to be that any advertisement that contained both the name of the drug being promoted and the disease or infirmity it was meant to remedy had to disclose all the drug's side effects. Because these can be voluminous, it made television and radio advertising impractical unless the drug's name or the illness it treated was left out. This state of affairs led to consumer confusion over what drug advertisements were actually trying to sell, and for what purpose. Therefore, the FDA in 1997 issued new guidelines that allowed for advertisement of pharmaceutical products without as much disclosure information as long as the major side effects were listed and a reference was made to a toll-free telephone number or Web site where further information could be obtained.

When these regulations are violated, the FDA may send the offending company one of two types of letters: an untitled letter or a warning letter. Other enforcement options available to the agency are injunctions or consent decrees, referrals for prosecution or seizure. Untitled letters address violations like overstating a product's capabilities or making misleading claims. Warning letters are sent when the infraction is more serious, as when a serious health risk is identified or when the offending company has had repeated violations. Under a directive issued to the FDA by the Department of Health and Human Services in November 2001, all Warning Letters and untitled letters that originate within the FDA must be reviewed and cleared by the Agency's Office of the Chief Counsel (OCC) before issuance. Under this system, a firm that receives a DDMAC letter is on notice that OCC has already determined that enforcement action based on the cited violation stands a relatively high likelihood of succeeding in court.

Since the rules on advertising were liberalized, pharmaceutical product commercials on television and radio have proliferated like mushrooms.

Concerns from Outside the Industry

Although it might be supposed that PhRMA's new policies on DTC advertising would put a lot of the critics' minds at ease, such is not necessarily the case. One problem often cited by those who want to see drug advertising halted or curtailed is that PhRMA's new policies are simply that: policies. Pharmaceutical companies can choose to agree to follow them … or not.

Many companies have already agreed to comply with the PhRMA policies, and more will undoubtedly sign on, if for nothing more than the positive publicity that comes from appearing to want to do the right thing, but not all will jump on the bandwagon. And, because the PhRMA policies are voluntary and PhRMA has determined that no contract will be required for a manufacturer to be considered a “signatory” to the pact (all a pharmaceutical company has to do is announce that it intends to follow the PhRMA plan to be named a signatory), the rules have no teeth.

Rob Schneider, director of the prescription drug reform effort at Consumer's Union, denounced the PhRMA policies as a mere “goodwill gesture” aimed at halting a movement toward more governmental regulation of DTC advertising.

One of the major reforms PhRMA calls for is that companies submit their advertisements to the FDA for viewing and commentary prior to printing or airing them, rather than make such submissions after the fact. However, according to a 2002 General Accounting Office (GAO) study titled, “Prescription Drugs: FDA Oversight of Direct-to-Consumer Advertising Has Limitations,” the FDA is very badly equipped to review even those advertisements it received complaints about. With more than 40,000 pieces of highly technical print, audio and video advertisement presented in the media each year, the 40-person team in charge of reviewing allegedly false or misleading ads was already stretched too thin between 1997 and the time of the study's publication. The GAO study also noted that the FDA's response times to false and misleading advertisements was sluggish, in large part due to the requirement imposed in 2001 that Warning Letters and untitled letters be reviewed by the OCC before issuance. The letters were getting bogged down in counsel's office while the advertisements they addressed continued to run unabated. If drug companies submit their promotions for review prior to releasing them to the public, as the PhRMA policies dictate, there may be not positive practical effect, as there is likely to be inadequate manpower to accomplish all the reviews and critiques necessary.

Comments on the Guidelines

Sidney Wolfe, MD, the director of consumer group Public Citizen's Health Research Group, likened the new guidelines to false and misleading drug advertisements. Dr. Wolfe called for three reforms that he said “would actually make a difference in this serious problem of misleading drug ads.” His proposed changes are: 1) that there be a significant increase in FDA enforcement actions concerning illegal ads; 2) that Congress be authorized to impose stiff fines on companies that violate drug advertising laws; and 3) that the FDA be given the legal authority to require that all television advertisements be approved by it before they can be screened.

Senate Majority Leader Bill Frist (R-TN), a surgeon who graduated with honors from Harvard Medical School, believes that DTC advertising leapfrogs over the doctor/patient dialog and raises national health care costs by creating demand for expensive drugs, sometimes with misleading information. Sen. Frist made a proposal this summer, before the PhRMA rules were published, that drug manufacturers institute a voluntary moratorium on pharmaceutical advertisement in the first two years following entry of a new drug on the market. His reasoning was that a two-year period of time would allow physicians to become familiar with a new drug so that they would not be caught off guard by patients asking for it. Doctors could take note of patients' reactions to the newly prescribed drugs, allowing them time to form an opinion as to the safety and efficacy of a medication before a flood of requests came in from patients.

Sen. Frist has asked for an updated GAO study that will show, among other things, if the FDA is now any better equipped to review drug advertisements for accuracy and balance than it was when the agency first reported on FDA review capacity in 2002. Although Sen. Frist announced that he was heartened by the PhRMA's move, he also sounded a cautious note. “I look forward to reviewing the comprehensive GAO study that I requested and plan to closely monitor the situation, assessing whether PhRMA's voluntary guidelines, individual companies' efforts to self-regulate their advertising practices, and FDA action to revise the agency's guidelines go far enough in stemming the tide of often unbalanced and misleading DTC advertising.”

When the Pharmaceutical and Research Manufacturers of America (PhRMA) announced it was instituting a new policy on direct-to-consumer advertising, PhRMA President and CEO Billy Tauzin stated, “With these principles, we commit ourselves to improving the inherent educational value of advertisements. Patients need accurate and timely information and should be encouraged to discuss diseases and treatment options with their physicians. These principles will help us reach that goal.”

These words epitomize the pharmaceutical industry's official position on the efficacy and advisability of DTC advertising. Debate continues, however, in health care professional, consumer and legislative circles over whether DTC pharmaceutical advertising should be permitted at all, and, if so, how it should be regulated. Supporters of DTC advertising describe it as an educational tool to help inform consumers of an illness they might have but are unable to find a diagnosis for and of the methods of treatment they might not otherwise learn of through their doctors or other sources. Opposition to pharmaceutical advertisements being placed in the popular media generally focuses on the potential interference with the doctor/patient relationship, the ease with which advertisements can disseminate false or misleading claims, creation of a demand for more expensive drugs over less costly medications that could achieve the same goals and diversion of drug manufacturers' funds away from research and development.

Like DTC advertising itself, PhRMA's stated policies on the subject have received a mixed reaction from various sectors of the public.

Regulation of Drug Advertising: A Short History

In 1906, with the passage of the Federal Food and Drugs Act, the Food and Drug Administration (FDA) gained its current name and added regulatory functions to its previous scientific mission. One of the matters the FDA attempted to regulate was false therapeutic claims made by “patent medicine” makers, but in the early days of the agency's forays into regulation of drug selling the courts were less than supportive. In 1911, the U.S. Supreme Court ruled that the 1906 law did not – contrary to the government's interpretation – apply to false therapeutic claims. An amendment in 1912 attempted to correct the law's language to allow better enforcement mechanisms for misbranding, but it required a showing of intent to defraud, a difficult standard for the agency to meet. Because of this, the FDA was powerless to protect the public from dangerous pharmaceutical products such as Banbar, a worthless “cure” for diabetes and Radithor, a radium-containing tonic that slowly and painfully killed its users, both of which the old law protected.

The agency and many in the public sector wanted the FDA to have more oversight authority over the drug industry, but a groundswell for change came only in 1937 when an untested medicine containing a chemical analogous to antifreeze was marketed for pediatric use and killed more than 100 people. The year following that disaster, and the public outcry that ensued, the Food, Drug and Cosmetics Act of 1938 was passed. It required drugs to be labeled with adequate directions for safe use and mandated pre-market approval of all new pharmaceutical products. While it also unequivocally prohibited false therapeutic claims for drugs, a separate law granted the Federal Trade Commission jurisdiction over drug advertising.

The Division of Drug Marketing, Advertising, and Communications (DDMAC) within FDA's Center for Drug Evaluation and Research (CDER) is now responsible for overseeing DTC advertising. Under the regulations, pharmaceutical companies are required to submit all drug advertisements to the FDA when they are first disseminated to the public, not before. It used to be that any advertisement that contained both the name of the drug being promoted and the disease or infirmity it was meant to remedy had to disclose all the drug's side effects. Because these can be voluminous, it made television and radio advertising impractical unless the drug's name or the illness it treated was left out. This state of affairs led to consumer confusion over what drug advertisements were actually trying to sell, and for what purpose. Therefore, the FDA in 1997 issued new guidelines that allowed for advertisement of pharmaceutical products without as much disclosure information as long as the major side effects were listed and a reference was made to a toll-free telephone number or Web site where further information could be obtained.

When these regulations are violated, the FDA may send the offending company one of two types of letters: an untitled letter or a warning letter. Other enforcement options available to the agency are injunctions or consent decrees, referrals for prosecution or seizure. Untitled letters address violations like overstating a product's capabilities or making misleading claims. Warning letters are sent when the infraction is more serious, as when a serious health risk is identified or when the offending company has had repeated violations. Under a directive issued to the FDA by the Department of Health and Human Services in November 2001, all Warning Letters and untitled letters that originate within the FDA must be reviewed and cleared by the Agency's Office of the Chief Counsel (OCC) before issuance. Under this system, a firm that receives a DDMAC letter is on notice that OCC has already determined that enforcement action based on the cited violation stands a relatively high likelihood of succeeding in court.

Since the rules on advertising were liberalized, pharmaceutical product commercials on television and radio have proliferated like mushrooms.

Concerns from Outside the Industry

Although it might be supposed that PhRMA's new policies on DTC advertising would put a lot of the critics' minds at ease, such is not necessarily the case. One problem often cited by those who want to see drug advertising halted or curtailed is that PhRMA's new policies are simply that: policies. Pharmaceutical companies can choose to agree to follow them … or not.

Many companies have already agreed to comply with the PhRMA policies, and more will undoubtedly sign on, if for nothing more than the positive publicity that comes from appearing to want to do the right thing, but not all will jump on the bandwagon. And, because the PhRMA policies are voluntary and PhRMA has determined that no contract will be required for a manufacturer to be considered a “signatory” to the pact (all a pharmaceutical company has to do is announce that it intends to follow the PhRMA plan to be named a signatory), the rules have no teeth.

Rob Schneider, director of the prescription drug reform effort at Consumer's Union, denounced the PhRMA policies as a mere “goodwill gesture” aimed at halting a movement toward more governmental regulation of DTC advertising.

One of the major reforms PhRMA calls for is that companies submit their advertisements to the FDA for viewing and commentary prior to printing or airing them, rather than make such submissions after the fact. However, according to a 2002 General Accounting Office (GAO) study titled, “Prescription Drugs: FDA Oversight of Direct-to-Consumer Advertising Has Limitations,” the FDA is very badly equipped to review even those advertisements it received complaints about. With more than 40,000 pieces of highly technical print, audio and video advertisement presented in the media each year, the 40-person team in charge of reviewing allegedly false or misleading ads was already stretched too thin between 1997 and the time of the study's publication. The GAO study also noted that the FDA's response times to false and misleading advertisements was sluggish, in large part due to the requirement imposed in 2001 that Warning Letters and untitled letters be reviewed by the OCC before issuance. The letters were getting bogged down in counsel's office while the advertisements they addressed continued to run unabated. If drug companies submit their promotions for review prior to releasing them to the public, as the PhRMA policies dictate, there may be not positive practical effect, as there is likely to be inadequate manpower to accomplish all the reviews and critiques necessary.

Comments on the Guidelines

Sidney Wolfe, MD, the director of consumer group Public Citizen's Health Research Group, likened the new guidelines to false and misleading drug advertisements. Dr. Wolfe called for three reforms that he said “would actually make a difference in this serious problem of misleading drug ads.” His proposed changes are: 1) that there be a significant increase in FDA enforcement actions concerning illegal ads; 2) that Congress be authorized to impose stiff fines on companies that violate drug advertising laws; and 3) that the FDA be given the legal authority to require that all television advertisements be approved by it before they can be screened.

Senate Majority Leader Bill Frist (R-TN), a surgeon who graduated with honors from Harvard Medical School, believes that DTC advertising leapfrogs over the doctor/patient dialog and raises national health care costs by creating demand for expensive drugs, sometimes with misleading information. Sen. Frist made a proposal this summer, before the PhRMA rules were published, that drug manufacturers institute a voluntary moratorium on pharmaceutical advertisement in the first two years following entry of a new drug on the market. His reasoning was that a two-year period of time would allow physicians to become familiar with a new drug so that they would not be caught off guard by patients asking for it. Doctors could take note of patients' reactions to the newly prescribed drugs, allowing them time to form an opinion as to the safety and efficacy of a medication before a flood of requests came in from patients.

Sen. Frist has asked for an updated GAO study that will show, among other things, if the FDA is now any better equipped to review drug advertisements for accuracy and balance than it was when the agency first reported on FDA review capacity in 2002. Although Sen. Frist announced that he was heartened by the PhRMA's move, he also sounded a cautious note. “I look forward to reviewing the comprehensive GAO study that I requested and plan to closely monitor the situation, assessing whether PhRMA's voluntary guidelines, individual companies' efforts to self-regulate their advertising practices, and FDA action to revise the agency's guidelines go far enough in stemming the tide of often unbalanced and misleading DTC advertising.”