Basics Of Pharmaceuticals

Aside from the requisites of drug manufacturing, a drug company must also have the knowledge on the legal aspect of the pharmaceutical business. A company must be able to know what agencies of the government he has to seek advice from before it undergoes the manufacturing process in order to have a good start.

Relative to this, the company needs to know which regulates the safety and efficacy of the drugs to be manufactured and which agency protects the rights of the manufacturer and the consumers against illicit drugs.

This paper will discuss the basic responsibilities of the Food and Drug Administration and the Drug Enforcement Agency including the approval process of manufacturing a generic drug copy. FOOD AND DRUG ADMINISTRATION AND ITS RESPONSIBILITIES The Food and Drug Administration (FDA) is generally responsible for ensuring the safety and efficacy of all drugs for human and veterinary use.

FDA’s 1mission statement specifically states that the administration “is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. ” This will then give us the idea why FDA need to regulate drugs, and that is to ensure that they are safe and effective. The administration is also held responsible for ensuring that the drugs have information that is honest and accurate for the general public to use.

The Drug Enforcement Agency (DEA) (Drug Enforcement Administration for the United States) is primarily responsible for the enforcement of the Controlled Substances Laws and Regulations. In the United States, DEA is under the wing of the Department of Justice, where it serves as an arm of the justice against the 2those organizations and principal members of organizations, involved in the growing, manufacture, or distribution of controlled substances appearing in or destined for illicit traffic in the United States. The DEA’s drugs of concern include: Cocaine, marijuana, heroin, inhalants, LSD, Ecstasy, Steroids, Oxycontin and Methamphetamine.

The following list of specific responsibilities is adopted by this writer from the DEA’s official website: >Investigation and preparation for the prosecution of major violators of controlled substance laws operating at interstate and international levels. >Investigation and preparation for prosecution of criminals and drug gangs who perpetrate violence in our communities and terrorize citizens through fear and intimidation. >Management of a national drug intelligence program in cooperation with federal, state, local, and foreign officials to collect, analyze, and disseminate strategic and operational drug intelligence information.

>Seizure and forfeiture of assets derived from, traceable to, or intended to be used for illicit drug trafficking. >Enforcement of the provisions of the Controlled Substances Act as they pertain to the manufacture, distribution, and dispensing of legally produced controlled substances. >Coordination and cooperation with federal, state and local law enforcement officials on mutual drug enforcement efforts and enhancement of such efforts through exploitation of potential interstate and international investigations beyond local or limited federal jurisdictions and resources.

>Coordination and cooperation with federal, state, and local agencies, and with foreign governments, in programs designed to reduce the availability of illicit abuse-type drugs on the United States market through nonenforcement methods such as crop eradication, crop substitution, and training of foreign officials. >Responsibility, under the policy guidance of the Secretary of State and U. S. Ambassadors, for all programs associated with drug law enforcement counterparts in foreign countries.

>Liaison with the United Nations, Interpol, and other organizations on matters relating to international drug control programs. DEA’S PROGRAMS AND OPERATIONS Drug Enforcement Agency also updates its programs and operations according to the demand of technology and the development of new methods of illicit drug operations. Recent report published in the KT4 Online alerted the public on the emergence of illegal websites that are bringing prescription drugs out into the market (KT4 Online, August 24, 2007).

The DEA reported that such websites are able to market their products using just credit cards as payment modes. The agency now referred the so-called “rogue pharmacies” to the congress for the legislation of a more formidable law for such illegal and dangerous activities, which are regulated because such companies do not meet the standards set by the United States. Even medicinal or herbal plants that are not yet studied or regulated under the law is also under the responsibility of the DEA to study and made research relative to its danger in the human health.

In Utah, a native plant called salvia divinorium, has been put into attention by the Hill Air Force Base which according to initial findings can cause hallucinations. In the report published in the Salt Lake Tribune, “magic mint” as its street name, is ingested or inhaled usually by the members of the military and the people inside the base (Salt Lake Tribune, August 20, 2007). The herbal plant is still legal as it is still under research by the DEA. Experts also say that the plant that grows in the wilds of Utah can cause lung irritation when its dried leaves are inhaled.

LAWS AND POLICIES GOVERNING GENERIC DRUGS The regulations pertaining to generics drugs are under the responsibility of the Food and Drug Administration. Under the law, pharmaceutical companies or drug manufacturers have all the right to apply for a generic copy of their branded drugs. It can also be that a manufacturer seeks for a license from the brand name company to make a generic copy of the branded product. A generic copy of the drug is called “authorized generics” because the branded product manufacturer had given the authority to the manufacturer of the generic drug copy.

However, these generic copied have to undergo the legal process that is regulated by the FDA. It is the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Waxman-Hatch Act, which is being used as a legal basis for FDA for regulating generic drug copies. “Since the law was enacted over 23 years ago, the number of generic manufacturers and number of generic drug products on the market have expanded exponentially” (Coster, John M. 2007). The law allows a generic drug that is a generic copy of the pioneer drug to be approved by FDA to be marketed by the same company.

This is even without the submission of the usual New Drug Application (NDA) that is submitted in full when a branded product is being applied for marketing. The NDA is usually a time-consuming and expensive clinical trials required to be done by the drug manufacturer in order to comply with the safety and efficacy standards required of them. With the Waxman-Hatch Act, NDA is being replaced with the submission of Abbreviated New Drug Application (ANDA) provided that the generic copy has demonstrated the fact that it is bioequivalent to the pioneer drug (J.

Coster, The Pharmacist, Vol. 32, No. 6, 2007). This process allows the generic copy to be approved for marketing the easier and faster way because it does not to prove its safety and effectiveness through trials since the pioneer drug had already proven such. For the ANDA of the generic drug to be approved, its pioneer drug must have the four required certifications: (1) that no patent is listed for the pioneer drug; (2) that the patent has expired; (3) the date on which the patent will expire; or (4) that the patent is invalid or not infringed.

Such information is listed in the FDA’s Orange Book, a reference for the pharmacists in determining the interchangeability of the drugs. Just recently, the Waxman-Hatch Act has been replaced with 3McCain-Schumer Act, after its authors Senators John McCain and Charles E. Schumer. The main feature of the new act is the changing of the 180-day exclusivity term of the first generic drug copy to only the 30-day term. Exclusivity, in the old law is granted for the manufacturer of the generic drug to market the product exclusively within 180 days that is for the manufacturer who first secured the FDA’s approval of the generic copy.

With the new law, exclusivity term is shortened for the purpose of further price reduction of the generic drugs as competition is encouraged after the 30-day term. It is estimated, according to Schumer’s study that the new law will enable consumers to save 60% of their usual expense when buying branded drugs and that will give consumers a total of $71 billion savings in 10 years (Bash, Dana, CNN Online, May 01, 2001). Schumer cited Claritin, a prescription allergy drug as example which costs an average of $63.

65 while its generic equivalent will only cost $25. 46. Generally, the new law is of great help for the Americans in terms of their medical expenditures. CONCLUSION By looking into the basic responsibilities and functions of the FDA and DEA, we were able to have an idea of the basic legal aspect of drug manufacturing and marketing. Also by having an overview of the laws governing generic copy manufacturing, we were able to have the basic knowledge of how the approval process rolls.

In general we can conclude that the legal process of drug manufacturing and marketing is really a long and expensive process for the companies especially for the branded or patented drugs. However with the Schumer-McCain Act, the process is shortened and had benefited especially the consumers for enabling the cheaper version of their branded medicine to be marketed. REFERENCES 1FDAs Mission Statement. Retrieved on August 26, 2007 from http://www. fda. gov/opacom/morechoices/mission. html 2DEA Mission Statement. Retrieved on August 26, 2007 from http://www.

usdoj. gov/dea/agency/mission. htm 3Senate Passes Ground-Breaking Schumer-McCain Generic Drug Bill (Press Release). July 31, 2002. Retrieved on August 26, 2007 from http://schumer. senate. gov/SchumerWebsite/pressroom/press_releases/PR01124. html Bash, Dana. McCain, Schumer introduce generic drug bill. CNN Online. May 01, 2001. Retrieved on August 26, 2007 from http://archives. cnn. com/2001/ALLPOLITICS/05/01/senate. genericdrugs/index. html Coster, John M. The Waxman-Hatch Generic Drug Law: 23 Years Later. The Pharmacist. June 19, 2007. Vol. 32 No. 6

Griffith, Christopher, et. al. (2002). View from Washington: Senate approves changes in generic-drug approval. Leydig, Voit Mayer, Ltd. Report. October 2002. Volume 3 Issue 4 Colonel bans use of ‘magic mint’ herb. Salt Lake Tribune. August 20, 2007. Retrieved on August 26, 2007 from http://www. sltrib. com/News/ci_6668009 Federal Authorities Warn Against Online Rogue Pharmacies. KT4 Online. Retrieved on August 26, 2007 from http://www. ktiv. com/News/index. php? ID=16295 What FDA Regulates. Retrieved on August 26, 2007 from http://www. fda. gov/comments/regs. html