Herbal Medication vs. Prescription Medication sample essay

The Food and Drug Administration (FDA) could make many improvements in the way it protects consumers from risks of prescriptions medicines. Although postmarket surveillance of adverse reaction to pharmaceuticals has been enhanced recently, from the critical point of view, many questions still remain to be unresolved or resolved partially, in particular drug compounding by pharmacists, control over imports of unapproved drugs, direct-to-consumer (DTC) prescription drug advertising and commercials of medication.

The Prescription Drug Marketing Act (PDMA) of 1988 gives the FDA with the authority to track illegal drug imports in the United States. PDMA imposes on wholesalers responsibility of keeping paper records of a drug’s source and distribution history in order to provide a pedigree for prescription products. Due to high cost of tracking requirements and thus numerous objections from wholesalers, the FDA has failed to complete PDMA’s implementing regulations. Simultaneously, contemporary situation on market of counterfeit products is putting pressure on FDA to implement the tracking program. The FDA initiated 22 counterfeit drug cases in 2003 and 20 cases in 2002. Since 1996, FDA investigations of counterfeiting cases resulted in 44 arrests and 27 convictions, involving high-volume drugs not only like AIDS therapies, antidepressants, and statins, but significant quantities of herbal medications. From practical point of view, FDA officials cooperate with manufacturers and foreign governments to stem widespread bogus drug marketing in both developing and developed countries. The FDA indicates that Chinese counterfeiting of some drugs may be as high as 50%, and estimates are about 40% for fake pharmaceuticals in Argentina, Colombia, and Mexico (Weissman, 103).

While direct-to-consumer (DTC) prescription drug advertising in the United States continues to grow exponentially, all stakeholders continue to either question its value or fight for its continued existence. Legislators, drug manufacturers, advertising agencies, the FDA, managed care organizations, and consumers are currently debating the value of advertising prescription drugs directly to consumers (Friedler, 485). Perhaps no other form of consumer advertising has caused such heated debate in recent history. Regardless of one's viewpoint, more research is needed to answer important questions surrounding this form of communication. The FDA "encourages sponsors and other interested parties to make known their research relating to the overall effects of DTC promotion on public health" (FDA 1999, 4)

The promise of direct-to-consumer (DTC) prescription drug advertising lies in its potential to educate consumers about medical conditions and the possibility of treatment. However, this promise comes with significant peril. The responsibility for ensuring that this information is clear and accurate falls on the FDA. For the past several specialists and industry analysts have been assessing the effectiveness of FDA regulation of prescription drug ads. It has been found that although the law prohibits manufacturers from making false and misleading claims about their products, the FDA is doing a poor job of enforcing this essential requirement. In November 2002 it was indicated that FDA enforcement actions against false and misleading drug ads declined precipitously in 2002, falling by more than 70 percent compared with the period from 1999 to 2000 (Weissman, 108). Moreover, the decline could not be explained by a change in the number of drug ads reviewed by the FDA, which increased, or a drop in complaints about ad content.

In January 2004, the issue has been revisited in an effort to determine whether the FDA had made progress in enforcing provisions barring false and misleading advertisements (Scussa, 215). Despite the FDA's promises, the investigation showed a continued decline in enforcement. It also showed that FDA delays in responding to false and misleading advertisements are getting longer. In 2003 the average delay between the placement of a false and misleading ad and an FDA action in response to that ad was 177 days-almost six months. In one case, the FDA did not send a warning letter until more than a year after the false and misleading advertisement had first appeared. In addition, the study revealed that FDA actions had little deterrent effect. The FDA's enforcement actions in 2003 were restricted to sending warning letters to drug manufacturers requesting that they cease running an advertisement. Although the FDA has the authority to take stronger actions with more deterrent effect, such as court actions or ultimately fines, the agency has not done so. In February 2004 the FDA released two guidance documents regarding prescription drug advertisements, one focusing on the risk and side-effect information provided to consumers alongside print advertisements and the second focusing on "help seeking" and other disease-awareness ads by drug companies.

Traditionally, pharmaceutical manufacturers directed their prescription drug advertising toward physicians. This makes sense because physicians have the final authority to prescribe drugs in the United States. Companies began to advertise directly to consumers in 1985 when the FDA lifted the ban on DTC advertisements. DTC advertising began to appear at that time, but it was minimal. The FDA had no specific regulations for DTC advertising, so the ads were subject to the same regulation as ads for health care professionals, including the technically worded "brief summary."

In August 1997, the FDA lifted the requirement to include the "brief summary" in broadcast advertising, and immediately thereafter drug manufacturers began to expand their television campaigns (FDA 1997, 2). In addition, the FDA made it clear that advertisers may omit the brief summary if they make "adequate provision ... for dissemination of the approved or permitted package labeling in connection with the

broadcast presentation" (FDA 1997, 3).

In 1999, the FDA outlined the approach "that the FDA believes can fulfill the requirement for adequate provision in connection with consumer-directed broadcast advertisements for prescription drug and herbal medications" (FDA 1997, 2). The FDA presumes that the ads

1. Are not false or misleading in any respect.

2. Present a fair balance between information about effectiveness and information about risk.

3. Include a thorough major statement conveying all of the product's most important risk information in consumer-friendly language.

4. Communicate all information relevant to the product's indication (including limitation to use) in consumer-friendly language. (FDA 1999, 2)

The FDAs requirement of fulfilling the "adequate provision" entails an approach that "will allow most of a potentially diverse audience to have reasonably convenient access to the advertised product's approved labeling" (FDA 1999, p. 2). The FDA then goes on to explain different ways the provision may be met: toll-free telephone numbers, print advertisements appearing concurrently with a broadcast campaign with the prescribing information available, disclosure that pharmacists, physicians (or other health care providers), or veterinarians may provide additional product information, and, finally, the disclosure of an Internet Web page (URL) address that contains the additional information (FDA 1999).

Ensuring that new drugs are used safely and sufficiently after they are distributed the market is a growing concern among FDA officials. Simultaneously, the FDA office particularly questions efficiency of the traditional risk strategies to deal with current safety problems. Contemporary techniques for preventing consumers’ risky behavior, in particular, changing labels, adding black-box warnings, medication guides are considered to be extremely ineffective in regard to gaining of desired response from physicians, practitioners and general public. Determined to enhance its initial strategy, the FDA develops new approaches to reducing risk associated with both herbal and prescription drugs, though the latter constitutes the aspect of primary concern. Thus, the FDA specialists develop specific risk management procedures, in particular requiring patients to sign agreements or informed consent forms showing that they have been informed about risks associated with the therapy and will follow certain procedures to avoid unsafe practices, monitoring product distribution, often through the use of centralized warehouses and a limited number of pharmacies, and keeping registries of patients, physicians, and pharmacies who participate in a risk management program.

Bibliography

1. Friedler, E. (1997). The Evolving Doctor-Patient to Provider-Consumer Relationship. Journal of Family Practice, 45(8)

2. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (1997). Draft Guidance for Industry: Consumer-Directed Broadcast Advertisements. Federal Register, 62, no. 155

3. Food and Drug Administration (1999). Guidance for Industry: Consumer-Directed Broadcast Advertisements. Federal Register, 64(152)

4. Scussa, Frank (2001). Getting Noticed: The Future of Consumer Promotion Is Being Challenged by Government Agencies and the Public, MedAdNews, 20 (6)

5. Weissman J.S (2004). Drugs and Regulation. Health Affairs 18(7)
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