Summary: Current FDA Regulations

The Food and Drug Administration (FDA) is best known for its role on protecting the health of the public by making sure that food, medications are safe and effective. Especially when it comes to the pharmaceutical industry, its mission is to regulate pharmaceutical manufacturers, as well as the drug approval process. However, in the recent years, many arguments and controversy regarding drug development and regulation have risen. Drug advertisements make false and misleading claims, products are being put out on the market without any proof of safety, causing many unwanted incidents such as the Avandia incident and Vioxx incident, which could have been prevented in the first place.

Pharmaceutical companies are provided with temporary monopoly rights on the production of new drugs which result in a higher cost on consumers. If competing companies were allowed to produce generic forms of those drugs, consumers will be able to afford those medications even in cases where those consumers have no insurance coverage. The company responsible for developing and inventing the original medication could be offered incentives to invent in the future by either obtaining tax breaks or NIH funding for future research. They could even be offered a percentage of the sales of the generic drugs. Economist Gary S. Becker advocates dropping many FDA requirements that, in his opinion, provide no additional safety measures but rather delay the development of new drugs.[12] Betamethasone, for example, has been part of the standard prenatal care in Europe since the late 1970’s while it got adopted in the U.S. after 1997. On many occasions, the FDA ignores all scientific evidence concerning certain drugs because the manufacturer did not follow their mandated bureaucratic standards.

Despite this, the industry did not alter its ways, maintaining that its ad campaigns were "educational," and that people were able to make their own decisions about what they purchased (Payer 66). However, it is evident that the advertisements produced by the pharmaceutical industry are designed for the very purpose of making it difficult for people to make these decisions independently. This marketing produces a large number of often deceptive, misleading tactics which have a large influence on both consumers and medical practitioners. The chief beneficiaries of this marketing are not the consumers but the pharmaceutical companies themselves.

During this time the first DTC print advertisement for Merck an “antipneumococcal vaccine, Pneumovax(pneumococcal vaccine polyvalent) was printed in Reader’s Digest (Ventola).” That created a chain effect and shortly later “Boots Pharmaceuticals ran the first DTC broadcast advertisement, which promoted the lower price of its prescription brand of ibuprofen (Rufen), compared with Motrin (Ventola).” Today, the US pharmaceutical industry spends $3.1 billion on advertising prescription drugs directly to consumers.

I think Big Pharma companies skew their data very regularly. Although this is not ethical, it's practiced in this field because there is a certain probability calculated as it relates to side effects and ineffectiveness. For instance when we take Tylenol as a child we eventually become tolerant to the dosage. As we get older we need to increase the dosage even more than is advertised to get relief. The Pharma companies do not advertise that ALL pills have a toxicity level and will affect our organs at some point in time. Each pill is tested for toxicity levels before being released to the public. With that said, these companies take on a certain amount of acceptable risk when producing medication. The public has accepted this risk with

The Federal Food, Drug Administration is responsible for establishing the Code of Federal Regulations which outlines the rules and regulations governing pharmaceuticals. The rules are divided into sections and include guidance based on drug categories. Due to each person having varying reactions to pharmaceutical products not all side-effects are detected during clinical testing. The Federal Food, Drug Administration is responsible for sharing the information with consumers. However, it seems a bit unethical because the large pharmaceutical companies do not have to share all of side-effect information that may assist consumers in making its choice on whether to try a product or to not try a product. Through various survey’s it was discovered that consumers are under the opinion that pharmaceutical companies need to have improved internal controls to ensure their compliance with regulations. Due to physicians and pharmaceutical companies working together and are dependent on one another there needs to be controls in place that would have an unbiased view of the regulations. The government will need to continue introducing new regulations that will aide in monitoring the relationships.

When studies were shown not to support the film’s argument, they were occasionally argued to be irrelevant due to interested manufacturers funding (and possibly manipulating) the data within the studies for monetary gains. An example is when Dr. Mercola that the 90 studies that find aspartame to be harmless by Ralph G. Walton and the like, 90 percent of them are funded by corporate interest and that any independent studies find the exact opposite, insinuating fowl play in the

New Zealand is the only other developed nation in the world where prescription drugs are advertised directly to consumers. The American pharmaceutical industry used to abide by a term “ethical marketing,” meaning that drug companies could only market to physicians. On the other hand, there is a valid argument for allowing direct-to-consumer drug advertisements as the flow of information and transparency are beneficial. However, there obviously needs to be some checks and balances. This experiment began with a print advertisement in 1981 in Reader’s Digest and the first TV ad took place in 1983. At that time, the FDA had several rules in place requiring companies to offer a fair and balanced presentation. In sum, this was a responsible era of advertising.

Direct-to-consumer advertisements of prescription drugs have become common aspects in today's advertising mediums such as Television and magazines. Direct-to-consumer advertising has partially been brought by the development of the pharmaceutical marketplace. These developments have contributed to the presentation of more information to patients in attempts to make the health care system better. In the current pharmaceutical marketplace, advertising has become an important aspect for survival and growth in the health care outlets. For many health care outlets, television is regarded as the most efficient way for advertising in the pharmaceutical marketplace. While there are considerations on whether prescription drugs should be advertised to the general public, it's important to note that health care consumers should make their own choices.

These ads are necessary so that the development of new, life-changing drugs are able to occur. At what cost, though? DTC prescription drug ads are being promoted before long-term safety information is known. Vioxx, a pain medication, was advertised and prescribed for five years before being withdrawn from the market for causing strokes and heart attacks; “Vioxx was listed as the primary suspected cause of death in 4,540 mortalities…” (paragraph 7).

These new guidelines will allow for a 12-year period of data exclusivity for new branded biologics. During the 12- year period, rivals are not allowed to use any prior data to try to come up with their own product. Before, the passage of the ACA, the Federal Drug Administration (FDA), could not legally approve new biologic medicines because they had to have clinical trials. This law opened up the regulatory guidelines for the FDA to approve

The next level of concern arises with what exactly is being given out. While many pharmaceutical companies swear by their products, it is easy to forget that at the end of the day they are

“I have no doubt that such a study would show that only a small percent of people call the 800 number or log onto the website, which would imply that the information is not getting to customers. Then the FDA would have to confront the fact that they are settling for considerably less information being distributed, and that is probably not a good thing.”

For example, Vedula (2012) notes that FDA guidelines state pharmaceutical companies can use peer-reviewed articles to publicize evidence of a drug’s effectiveness for off-label uses, as long as a number of conditions are met—perhaps the most essential of which is that “the information disseminated must not be false or misleading.” However, Vedula continues, there is no unyielding regulation that all research findings have to be published. Therefore, a company can still choose to selectively disseminate favorable findings. His article concludes that there is now a copious amount of evidence that suggests selective reporting of study results, based on the strength and direction of findings, is performed extensively by the pharmaceutical industry.

Pharmaceutical companies should attempt to be as transparent as possible when marketing prescription drugs to the public. Their marketing efforts should not only convey the benefits of the prescription drug, but also easily convey the possible risks associated with the prescription drugs. Many patients may tend to think the benefits outweigh the potential risks of prescription drugs and may pressure their physician to prescribe it. Due to the way the prescription drug is marketed, the consumer may believe the