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Recent Developments Which May Impact Consumer Access to, and Demand for, Pharmaceuticals

Statement of

Janet Woodcock, M.D.,
Center for Drug Evaluation and Research
Food and Drug Administration
Department of Health and Human Services


the Subcommittee on Health
House Committee on Energy and Commerce

June 13, 2001   


Mr. Chairman and Members of the Subcommittee, I am Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA or the Agency). I am here today to update you on three important areas that CDER is continuing to work on:

(1) FDA's implementation of provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments) that govern the generic drug approval process.
(2) The promotion that manufacturers of prescription drugs (product sponsors) direct toward consumers and patients. This is referred to as "direct-to-consumer" promotion or DTC.
(3) The mechanism for reclassification of drugs from prescription to over-the-counter (OTC) status, namely, the request for the OTC switch by a third party, a novel situation FDA is presently facing.


FDA's implementation of provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments) govern the generic drug approval process. These provisions give 180 days of marketing exclusivity to certain generic drug applicants. The 180-day generic drug exclusivity provision is one component of the complex patent listing and certification process, which also provides for a 30-month stay on generic drug approvals while certain patent infringement issues are litigated.

The Hatch-Waxman Amendments are intended to balance two important public policy goals. First, drug manufacturers need meaningful market protection incentives to encourage the development of valuable new drugs. Second, once the statutory patent protection and marketing exclusivity for these new drugs has expired, the public benefits from the rapid availability of lower priced generic versions of the innovator drug.


The Hatch-Waxman Amendments amended the Federal Food, Drug, and Cosmetic (FD&C) Act and created section 505(j). Section 505(j) established the abbreviated new drug application (ANDA) approval process, which permits generic versions of previously approved innovator drugs to be approved without submission of a full new drug application (NDA). An ANDA refers to a previously approved NDA (the "listed drug") and relies upon the Agency's finding of safety and effectiveness for that drug product.

The timing of an ANDA approval depends in part on patent protections for the innovator drug. Innovator drug applicants must include in an NDA information about patents for the drug product that is the subject of the NDA. FDA publishes patent information on approved drug products in the Agency's publication "Approved Drug Products with Therapeutic Equivalence Evaluations" (the Orange Book) (described in more detail below). The FD&C Act requires that an ANDA contain a certification for each patent listed in the Orange Book for the innovator drug. This certification must state one of the following:

(I) that the required patent information relating to such patent has not been filed;
(II) that such patent has expired;
(III) that the patent will expire on a particular date; or
(IV) that such patent is invalid or will not be infringed by the drug, for which approval is being sought.

A certification under paragraph I or II permits the ANDA to be approved immediately, if it is otherwise eligible. A certification under paragraph III indicates that the ANDA may be approved on the patent expiration date.

A paragraph IV certification begins a process, in which the question of whether the listed patent is valid or will be infringed by the proposed generic product may be answered by the courts prior to the expiration of the patent. The ANDA applicant who files a paragraph IV certification to a listed patent must notify the patent owner and the NDA holder for the listed drug that it has filed an ANDA containing a patent challenge. The notice must include a detailed statement of the factual and legal basis for the ANDA applicant's opinion that the patent is not valid or will not be infringed. The submission of an ANDA for a drug product claimed in a patent is an infringing act if the generic product is intended to be marketed before expiration of the patent, and therefore, the ANDA applicant who submits an application containing a paragraph IV certification may be sued for patent infringement. If the NDA sponsor or patent owner files a patent infringement suit against the ANDA applicant within 45 days of the receipt of notice, FDA may not give final approval to the ANDA for at least 30 months from the date of the notice. This 30-month stay will apply unless the court reaches a decision earlier in the patent infringement case or otherwise orders a longer or shorter period for the stay.

The statute provides an incentive of 180 days of market exclusivity to the "first" generic applicant who challenges a listed patent by filing a paragraph IV certification and running the risk of having to defend a patent infringement suit. The statute provides that the first applicant to file a substantially complete ANDA containing a paragraph IV certification to a listed patent will be eligible for a 180-day period of exclusivity beginning either from the date it begins commercial marketing of the generic drug product, or from the date of a court decision finding the patent invalid, unenforceable or not infringed, whichever is first. These two events - first commercial marketing and a court decision favorable to the generic - are often called "triggering" events, because under the statute they can trigger the beginning of the 180-day exclusivity period.

In some circumstances, an applicant who obtains 180-day exclusivity may be the sole marketer of a generic competitor to the innovator product for 180 days. But 180-day exclusivity can begin to run - with a court decision - even before an applicant has received approval for its ANDA. In that case, some, or all, of the 180-day period could expire without the ANDA applicant marketing its generic drug. Conversely, if there is no court decision and the first applicant does not begin commercial marketing of the generic drug, there may be prolonged or indefinite delays in the beginning of the first applicant's 180-day exclusivity period. Approval of an ANDA has no effect on exclusivity, except if the sponsor begins to market the approved generic drug. Until an eligible ANDA applicant's 180-day exclusivity period has expired, FDA cannot approve subsequently submitted ANDAs for the same drug, even if the later ANDAs are otherwise ready for approval and the sponsors are willing to immediately begin marketing. Therefore, an ANDA applicant who is eligible for exclusivity is often in the position to delay all generic competition for the innovator product.

Only an application containing a paragraph IV certification may be eligible for exclusivity. If an applicant changes from a paragraph IV certification to a paragraph III certification, for example upon losing its patent infringement litigation, the ANDA will no longer be eligible for exclusivity.


This 180-day exclusivity provision has been the subject of considerable litigation and administrative review in recent years, as the courts, industry, and FDA have sought to interpret it in a way that is consistent both with the statutory text and with the legislative goals underlying the Hatch-Waxman Amendments. A series of Federal court decisions beginning with the 1998 Mova1 case describe acceptable interpretations of the 180-day exclusivity provision, identify potential problems in implementing the statute, and establish certain principles to be used by the Agency in interpreting the statute.

In light of the court decisions finding certain FDA regulations inconsistent with the statute, the Agency proposed new regulations in August 1999 to implement the 180-day exclusivity. Since then many comments have been submitted and there have been additional court decisions further interpreting the 180-day exclusivity provision and complicating the regulatory landscape. The Agency has not yet published a final rule on 180-day exclusivity. As described in a June 1998 guidance for industry, until new regulations are in place, FDA is addressing on a case-by-case basis those 180-day exclusivity issues not addressed by the existing regulations.

One of the most fundamental changes to the 180-day exclusivity program that has resulted from the legal challenges to FDA's regulations is the determination by the courts of the meaning of the phrase "court decision." The courts have determined that the "court decision" that can begin the running of the 180-day exclusivity period may be the decision of the district court, if it finds that the patent at issue is invalid, unenforceable, or will not be infringed by the generic drug product. FDA had interpreted the "court decision" that could begin the running of 180-day exclusivity (and the approval of the ANDA) as the final decision of a court from which no appeal can be or has been taken - generally a decision of the Federal Circuit. FDA's interpretation had meant that an ANDA applicant could wait until the appeals court had finally resolved the patent infringement or validity question before beginning the marketing of the generic drug. FDA had taken this position so that the generic manufacturer would not have to run the risk of being subject to potential treble damages for marketing the drug, if the appeals court ruled in favor of the patent holder. The current interpretation means that if the 180-day exclusivity is triggered by a decision favorable to the ANDA applicant in the district court, the ANDA sponsor who wishes to market during that exclusivity period now may run the risk of treble damages if the district court decision is reversed on appeal to the Federal Circuit. As a practical matter, it means that many generic applicants may choose not to market the generic and thus the 180-day exclusivity period could run during the pendency of an appeal.

In one of the cases rejecting FDA's interpretation of the "court decision" language in the statute, the court determined that the applicant who relied in good faith on FDA's interpretation of the 180-day exclusivity provision should not be punished by losing its exclusivity. The court, therefore, refused to order FDA to begin the running of 180-day exclusivity upon the decision of the district court in the patent litigation at issue. FDA has taken a similar approach in implementing the courts' decisions: the new "court decision" definition will apply only for those drugs for which the first ANDA was submitted subsequent to March 30, 2000. In adopting this course, a primary concern for the Agency was to identify an approach that would minimize further disruption and provide regulated industry with reasonable guidance for making future business decisions.

To advise the public and industry of this position, FDA published a Guidance for Industry in March 2000. FDA intends to incorporate the courts' interpretation of the "court decision" trigger for 180-day exclusivity into the final rule implementing the changes in 180-day exclusivity.


There have been concerns expressed over FDA's role in the listing of patents in the Orange Book, which can have an impact on generic drug approvals by delaying approval and 180-day exclusivity. Under the FD&C Act, pharmaceutical companies seeking to market innovator drugs must submit, as part of an NDA or supplement, information on any patent that 1) claims the pending or approved drug or a method of using the approved drug, and 2) for which a claim of patent infringement could reasonably be asserted against an unauthorized party. Patents that may be submitted are drug substance (active ingredient) patents, drug product (formulation and composition) patents, and method of use patents. Process (or manufacturing) patents may not be submitted to FDA.

When an NDA applicant submits a patent covering the formulation, composition, or method of using an approved drug, the applicant must also submit a signed declaration stating that the patent covers the formulation, composition, or use of the approved product. The required text of the declaration is described in FDA's regulations. FDA publishes patent information on approved drug products in the Orange Book.

The process of patent certification, notice to the NDA holder and patent owner, a 45-day waiting period, possible patent infringement litigation and the statutory 30-month stay mean there is the possibility of a considerable delay in the approval of ANDAs as a result of new patent listings. Therefore, these listings are often closely scrutinized by ANDA applicants. FDA regulations provide that, in the event of a dispute as to the accuracy or relevance of patent information submitted to and subsequently listed by FDA, an ANDA applicant must provide written notification of the grounds for dispute to the Agency. FDA then requests the NDA holder to confirm the correctness of the patent information and listing. Unless the patent information is withdrawn or amended by the NDA holder, FDA will not change the patent information listed in the Orange Book. If a patent is listed in the Orange Book, an applicant seeking approval for an ANDA must submit a certification to the patent. Even an applicant whose ANDA is pending when additional patents are submitted by the sponsor must certify to the new patents, unless the additional patents are submitted by the patent holder more than 30 days after issuance by the U.S. Patent and Trademark Office.

FDA does not undertake an independent review of the patents submitted by the NDA sponsor. FDA does not assess whether a submitted patent claims an approved drug and whether a claim of patent infringement could reasonably be made against an unauthorized use of the patented drug. FDA has implemented the statutory patent listing provisions by informing interested parties what patent information is to be submitted, who must submit the information, and when and where to submit the information. As the Agency has stated, since the implementation of the 1984 Hatch-Waxman Amendments began, FDA has no expertise or resources with which to resolve complex questions of patent coverage, and thus the Agency's role in the patent-listing process is ministerial. The statute requires FDA to publish patent information upon approval of the NDA. The Agency relies on the NDA holder or patent owner's signed declaration stating that the patent covers an approved drug product's formulation, composition or use. Generic and innovator firms may resolve any disputes concerning patents in private litigation. As noted above, if the generic applicant files a paragraph IV certification and is sued for patent infringement within 45 days, there is an automatic stay of 30 months, substantially delaying the approval of the generic drug and, thus, the availability of lower cost generic drug products.


FDA continues to implement the Hatch-Waxman Amendments exclusivity provisions in the best manner possible given the text of the legislation, the history of the legislation and the numerous court challenges. Again, as previously noted, FDA has tried to balance innovation in drug development and expediting the approval of lower-cost generic drugs.



The promotion that manufacturers of prescription drugs (product sponsors) direct toward consumers and patients is referred to as "direct-to-consumer" promotion or DTC. Such promotion uses multiple avenues for reaching lay audiences, including, but not limited to: television and radio advertisements, print advertisements, telephone advertisements, direct mail, videotapes and brochures. It is important to understand the scope of FDA's authority in this area. It is also important to understand the different types of advertisements that are directed toward consumer audiences. The FD&C Act and regulations do not distinguish between professional and consumer audiences. Section 502(n) of the FD&C Act specifies that prescription drug advertisements must contain "a true statement of . . . information in brief summary relating to side effects, contraindications, and effectiveness" of the advertised product. The implementing regulations (Title 21, Code of Federal Regulations [CFR] Section 202.1), originally issued in the 1960s, specify, among other things, that prescription drug advertisements cannot be false or misleading, cannot omit material facts, and must present a fair balance between effectiveness and risk information. Further, for print advertisements, the regulations specify that every risk addressed in the product's approved labeling must also be disclosed in the advertisements.

For broadcast advertisements, however, the regulations require ads to disclose the most significant risks that appear in the labeling. The regulations further require that the advertisement either contain a summary of "all necessary information related to side effects and contraindications" or convenient access must be provided to the product's FDA- approved labeling and the risk information it contains.

Finally, the FD&C Act specifically prohibits FDA from requiring prior approval of prescription drug advertisements, except under extraordinary circumstances. Also, the advertising provisions of the FD&C Act do not address the issue of drug product cost.


There are three different types of ads that product sponsors use to communicate with consumers: "product-claim" advertisements, "help-seeking" advertisements, and "reminder" advertisements. Advertisements that include both a product's name and its use, or that make any claims or representations about a prescription drug, are known as "product-claim" advertisements. These ads must include a "fair balance" of risks and benefits. In addition, they must provide all risk information included in the product's FDA-approved labeling or, for broadcast advertisements, provide convenient access to this information. In our regulations, the phrase "adequate provision" is used to identify the convenient access option. Unlike the "product claim" ads, "help-seeking" advertisements and "reminder" ads need not include any risk information.

A "help-seeking" advertisement discusses a disease or condition and advises the audience to "see your doctor" for possible treatments. Because no drug product is mentioned or implied, this type of ad is not considered to be a drug ad and FDA does not regulate it.

The second type of advertisement that does not need to include risk information is called a "reminder" advertisement. The regulations specifically exempt this type of ad from the risk disclosure requirements. Like "help-seeking" ads, the "reminder" ad is limited, although in a different way from "help-seeking" ads. "Reminder" ads are allowed to disclose the name of the product and certain specific descriptive (e.g., dosage form) or cost information, but they are not allowed to give the product's indication or dosage recommendations, or to make any claims or representations about the product. The exemption for "reminder" ads was included in FDA's regulations for promotions directed toward health care professionals, who presumably knew both the name of a product and its use. "Reminder" ads serve to remind health care professionals of a product's availability. They specifically are not allowed for products with serious warnings (called "black box" warnings) in their labeling.


Prior to the early 1980s, prescription products were not promoted directly to consumers and patients. Instead, product sponsors often produced materials that were given to health care professionals to pass on to patients if they thought this would be appropriate for particular patients. In the early 1980s, a few companies started advertising products directly to patient audiences (specifically, older people concerned about pneumonia and people taking prescription ibuprofen to treat arthritis pain). As a result of questions and concerns about promotion directed toward non-health care professionals, in 1983 FDA requested that sponsors suspend DTC ads to give the Agency time to study the issue.

The industry complied with this request, and during the ensuing moratorium FDA conducted research and sponsored a series of public meetings. In 1984, the University of Illinois and Stanford Research Institute jointly sponsored a symposium to discuss consumer-directed prescription drug advertising from a broad research and policy perspective. On September 9, 1985, FDA withdrew the moratorium in a Federal Register (FR) Notice (50 FR 36677), which stated that the "current regulations governing prescription drug advertising provide sufficient safeguards to protect consumers."

During the early 1990's, product sponsors increasingly used consumer magazines to advertise their products. These ads typically included a promotional message together with the "brief summary" of adverse effects, similar to that used in physician directed ads. The "brief summary" statement, which frequently appears in small print, is not very consumer friendly. In the 1990s, product sponsors also started using television advertisements in a limited fashion. Television advertisements were limited because FDA and industry did not believe that it was feasible to disseminate the product's approved labeling in connection with the ad. The extensive disclosure needed to fulfill this requirement essentially precluded the airing of such ads. For example, one way to satisfy this requirement would be to scroll the "brief summary," which would take a minute or more even at a barely readable scrolling rate. The industry, therefore, resorted to television ads that did not require risk disclosure.

By the mid-1990s, product sponsors started placing "reminder" ads on television. Because these ads only mentioned the name of the drug, however, they were extremely confusing to consumers, who, unlike health care professionals, were not knowledgeable about the name and the use for these products.

In response to increasing consumer demand for information, FDA began to consider whether broadcast advertisements could be constructed to ensure access to product labeling, the only alternative to including all of an advertised product's risk information. FDA considered suggestions about providing access to multiple sources of product labeling as a means of satisfying the requirement that consumers have convenient access to FDA-approved labeling when manufacturers broadcast a "product-claim" advertisement.

In August 1997, FDA issued a draft guidance entitled: "Guidance for Industry: Consumer-Directed Broadcast Advertisements" that clarified the Agency's interpretation of the existing regulations. The Guidance described an approach for ensuring that audiences exposed to prescription drug advertisements on television and radio have convenient access to the advertised product's approved labeling. The proposed mechanism consisted of reference in the broadcast advertisement to four sources of labeling information: a toll-free telephone number, a website address, a concurrently running print advertisement, and health care professionals. Following a comment period, and detailed review and consideration of the comments, FDA made only minor changes to the draft guidance, and issued it in final form in August 1999 (64 FR 43197, found in the FDA website). In announcing the final guidance, FDA advised that the Agency intended to evaluate the impact of the guidance, and of DTC promotion in general, on the public health, within two years of finalizing the guidance.


A number of stakeholder groups have expressed strong interest in DTC promotion. Those that are positive about DTC promotion assert that this practice will:

  • Improve consumers' knowledge of drugs and drug availability.
  • Encourage consumers to talk with their health care providers about their health problems.
  • Allow consumers and patients to have a greater role in decisions about their own health care that they say they desire.
  • Improve communication between patients and their physicians.
  • Improve appropriate prescribing by allowing physicians to get more information about their patients from their patients.
  • Lower the cost of prescription drugs. Not all stakeholders are positive about DTC promotion. Opponents assert that DTC advertising will:
  • Confuse consumers about drugs.
  • Make it appear that prescription drugs are safer than they are.
  • Interfere with the patient-physician relationship because patients will insist that their physicians prescribe the advertised products.
  • Increase inappropriate prescribing.
  • Raise the cost of prescription drugs.

Finally, there is a group of stakeholders with a less polarized view of DTC promotion. They believe that such promotion has both benefits and risks, but that it should be strictly regulated, and that, preferably, all DTC materials should be "pre-approved" by FDA. They often assert that there are potential public health benefits associated with patients visiting health care providers about untreated diseases or conditions, particularly those that appear to be under treated in the population and that are responsible for long-term harm (for example, high cholesterol, high blood pressure, diabetes and osteoporosis).


FDA recognizes that drug promotion raises certain issues for health care professionals and different issues for consumers, in light of differences in medical and pharmaceutical expertise. For this reason, FDA has monitored DTC promotion, and especially broadcast promotion, very closely to help ensure that adequate contextual and risk information, presented in understandable language, is included to fulfill the requirement for fair balance and to help the consumer accurately assess promotional claims and presentations.

Product sponsors of prescription advertisements are required to submit their promotional materials to FDA around the time these materials are initially put into public use. FDA receives approximately 32,000 of these submissions per year, for all types of promotion, including promotion to health care professionals. Product Sponsors also can submit draft materials to FDA for review and comment prior to using them. Division of Drug Marketing, Advertising and Communications (DDMAC) has made it a high priority to provide comments to product sponsors on voluntarily submitted draft broadcast advertisements within a reasonable time. In fact, although it is not required, a majority of product sponsors voluntarily submit their broadcast advertisements to DDMAC for prior review and comment at some point as advertising materials are being produced. Product sponsors may ask for review and comment at the very initial stages of production (by supplying the words they intend to use along with rough drawings of their proposed graphics), or at the later stages of final videotape production. DDMAC only gives final comments on final videotapes because inappropriate presentations can turn an otherwise acceptable advertisement into an unacceptable one (for example, by pacing the risk disclosure too rapidly, including multiple distracting visual images during the risk disclosure, or including images that overstate the efficacy of the product beyond what is supported by substantial clinical evidence).

Since January 1997, sponsors of about 65 prescription drugs have aired "product-claim" advertisements on television or radio. A small number of prescription biological products also have been advertised. Nine products fall into the allergy category (nasal and ocular anti-histamines, and nasally administered corticosteroids), while another eight products treat skin or hair-related problems (acne, cold sores, rosacea, baldness, unwanted facial hair, nail fungus). More importantly, ten products are designed to treat diseases that are believed to be under treated, including high cholesterol and heart disease, and mental health problems like depression. Five products to treat or prevent osteoporosis or menopausal symptoms have been advertised. Other advertised products are approved to treat such conditions or diseases as asthma, Alzheimer's Disease, arthritis, chronic obstructive pulmonary disease, diabetes, insomnia, migraine, obesity, overactive bladder, serious heartburn, smoking cessation, and sexually transmitted diseases. Most of these are serious problems where patients are in the best position to recognize symptoms.

It is important to note that DDMAC does not know how many different advertisements have aired in broadcast media for these 65 drugs. There have been multiple campaigns for a number of the products, including the allergy and high cholesterol products. In addition, many campaigns include different length "product-claim" commercials, as well as multiple short "reminder" commercials. DDMAC does not track the number of different broadcast advertisements that are submitted. Further, because "help-seeking" advertisements, if done properly, are not considered to be drug ads, most product sponsors do not send them to DDMAC under the submission requirements for prescription drug promotional materials. Therefore, we have no measure of how many of these have been in the public domain.


Since August 1997, FDA has issued:

  • 26 "untitled" (or "Notice of Violation") letters on "product-claim" broadcast advertisements. Such letters request that the violative promotion be stopped immediately. Product sponsors virtually always comply immediately with this request.
  • 3 "warning letters" on broadcast advertisements. This is a higher-level enforcement action, and requests that a remedial campaign be conducted by the company to correct the impressions left by the ad.
  • 13 "untitled" letters on purported "reminder" broadcast advertisements.
  • 3 "untitled" letters on purported "help-seeking" broadcast advertisements.

Most of the violations cited were because the ad overstated or guaranteed the product's efficacy, expanded the indication or the patient population approved for treatment, or minimized the risks of the product, through either inadequate presentation or omission of information.

Since January 1997, the Agency has issued:

  • 43 "untitled" letters that addressed DTC print advertisements or other promotional materials, including purported "reminder" and "help-seeking" materials.
  • 1 "warning letter" that included a DTC print advertisement as part of an overall misleading campaign.

    Generally, the violations involving print ads making "product-claim" ads were similar to those cited above. Nearly all "reminder" ad violations were the result of representations about the product that triggered the need for full disclosure of benefits and risks. "Help-seeking" ad violations were due to a particular product being implied in the message. As noted above, however, FDA cannot determine how many specific advertisements serve as the denominator for assessing how many have resulted in enforcement action compared with those that have not.


A number of groups have been conducting research on DTC promotion. Much publicly available research consists of surveys utilizing samples of consumers or patients to examine attitudes about DTC promotion and self-reported behaviors related to DTC promotion in the context of patient-physician visits and use of prescription drugs. The groups sponsoring this research include: Prevention magazine, TIME Inc., the National Consumers League, and American Association of Retirement People. A few surveys of physicians have been made partially publicly available. FDA remains concerned, however, about the representation of the physician surveys. In 1999, FDA sponsored a telephone survey that focused on a national probability sample of patients who had seen a physician for a problem on their own within the three months prior to the survey. The results of this patient survey suggested that patients are seeking additional information as a result of DTC promotions that they have seen. This information was sought primarily from health care professionals, and secondarily from reference texts and family. Generally, between 10 and 20 percent of respondents said that they sought additional information from the sources referenced in broadcast advertisements - toll-free telephone numbers, web sites, print advertisements. A major result, and one that is consistent with results of Prevention's national surveys, is that a significant minority of respondents said that a DTC ad has caused them to ask a doctor about a medical condition or illness they had not previously discussed. This could represent a significant and positive public health benefit, particularly if these patients are talking about undiagnosed heart disease or other serious disorders.

The survey results also suggest that DTC advertisements are not significantly increasing visits to a physician's office. For the most part, patients said that they had recently visited their doctors for the traditional reasons: because it was time for a check-up (53 percent), because they were feeling ill (42 percent), or because they had had a sudden symptom or illness (41 percent). Only two percent said that they had visited their doctor because of something they had seen or heard. Of those patients who had a conversation with their doctor about a prescription drug: 81 percent said that their doctor had welcomed the question, 79 percent said that their doctor discussed the drug with them, and 71 percent said that their doctor had reacted as though the conversation was an ordinary part of the visit. Only four percent said that their doctor seemed upset or angry when the patient asked about a prescription drug. According to the patients, therefore, physicians seem to be reacting well to questions about prescription drugs. Finally, only 50 percent of these patients said that their doctor gave them the medication discussed. Thirty-two percent said that the doctor recommended a different drug. Twenty-nine percent of the respondents indicated that behavioral or lifestyle changes were suggested by the doctor. It therefore appears, from FDA's data, that physicians are comfortable denying prescriptions when the prescription would not be right for the patient.

A small number of patients who were denied prescriptions said that their doctors told them why. Reasons included: the drug wasn't right for the patient; the doctor wanted the patient to take a different drug; the drug had side effects of which the patient was unaware; the patient did not have the condition treated by the drug; the patient did not need a prescription drug; the patient could use a non-prescription drug; and, there was a less expensive drug available

Patients also were asked about their attitudes about prescription drug advertisements. Their answers indicated somewhat mixed feelings. Eighty-six percent agreed that these ads help make them aware of new drugs, 70 percent agreed that the ads give enough information to help the patient decide if they should discuss the product with a doctor, and 62 percent agreed that ads help the patients have better discussions with their doctors about their health. Only 24 percent agreed that DTC ads make it seem like a doctor is not needed to decide whether a drug is right for someone. In contrast, 58 percent agreed that DTC ads make drugs seem better than they really are, 59 percent agreed that ads do not give enough information about the advertised product's risks and negative effects, and 49 percent agreed that these ads do not give enough information about the benefits and positive effects of the advertised product.


In issuing both the draft and the final broadcast advertisement guidance, FDA stated its intent to assess the impact of the guidance, and of DTC promotion in general, on the public health. FDA is also aware that privately funded research is being planned to examine the effects of DTC promotion. At present, FDA is not aware of any evidence that the risks of DTC promotion outweigh its benefits. FDA intends to carefully examine all available data, to determine whether the public health is adequately protected.


The FDA is responsible for the reclassification of many drugs from prescription to OTC status. These are often referred to as "switch drugs," and the reclassification process is referred to as "switching from prescription to OTC." Nearly forty ingredients incorporated into drug products have been reclassified since 1972 when the OTC drug review began.

Under the FDA's Office of OTC Drug Evaluation, a process was established for producing a final regulation to set standards for each drug product-treatment category. Nearly forty ingredients has been reclassified using this process since 1972 using this process.

Switches are covered by the prescription exemption procedures, found in 21 CFR 310.200. Switches can be initiated by FDA, the sponsor of a new drug application, or by any interested party. The OTC drug product can be marketed under a NDA or under the process established by regulation. The switch may be:

  • A complete switch whereby all of the indications and dosage forms are switched from prescription to OTC status;
  • A partial switch whereby some of the prescription indications and dose regimens are switched to OTC status and the others remain prescription.

Historically, the majority of drugs that have been switched from prescription-only to OTC marketing were at the initiated by the sponsor. The FD&C Act restricts drugs to prescription only status if a learned intermediary is required for the proper use of the drug. As written, the default assumption of the Act is for drugs to be marketed OTC without a prescription unless a decision is made that consumers are not able to appropriately diagnose their condition nor able to correctly choose the remedy and safely use it based on OTC labeling.

Anyone may submit a citizen petition. Individuals sometimes submit petitions, but most come from the regulated industry or consumer groups. For the first time, a third party has asked the FDA to reclassify a drug through the citizen petition process. Because the petition is still under review, we cannot comment on it at this time. FDA may use a wide range of public procedures (e.g., conferences, meetings, correspondence, hearings) during the process of evaluating the petition and to assist in the formulation of a final response.

In the process of responding to a petition, the Agency creates an administrative record, a comprehensive documentary foundation for the agency's final decision. The Agency's grant or denial of a petition, which usually is in the form of a letter to the petitioner, constitutes a final agency action. The Agency may also issue a tentative response explaining that the Agency has not yet reached a final decision on whether to grant or deny the petition. When FDA issues a final decision, however, it may be appealed through the court system.

As with any petition, FDA is studying the scientific and legal issues it raises in an effort to make the best science-based decision under the law.

We look forward to the Committee's continued interest in this area and would be happy to answer any questions.

1Mova Pharmaceutical Corp. v. Shalala,140 F.3d 1060, 1065 (D.C. Cir. 1998).