Regulating Pharmaceuticals




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April 10, 2015

Re:, Regulation

Regulationof Pharmaceuticals

Thedebate about whether there is adequate regulation of pharmaceuticalshas been ongoing. This essay looks into the issue ‘regulation ofpharmaceuticals by the government’ so as to protect the citizensagainst deaths that would otherwise have been prevented if there wereenough regulation.

Pharmaceuticalcompanies use doctors to perform tests on drugs. The drugs that weresupposed to help patients became their suicidal route (Katel, 863).The problem is that concern is always raised the moment there arecasualties among the patients who take the drugs. This has raised alot of debate on whether the prescription and effectiveness of thedrugs are properly monitored. The trend shows some reluctance on allstakeholders. After an uproar, the problem subsists, but aftersometime the same problem arises.

Thisproblem affects all the stakeholders. There is the question whetherthe government is doing enough. The doctors are also accused ofcorruption and accepting incentives from pharmaceutical companies toinfluence the distribution of the drugs. The government is one majorformal policy maker that creates bodies like The Food and DrugsAdministration. One informal policy maker that guides these policiesis the Pew Charitable Trusts that through critiquing, becomes part ofthe policy formulators who give word on the issue of drugs beingdistributed to the public. This body works in the interest of thepublic who would not be able to air their grievances.

Themain economic regulating authority for pharmaceuticals is the Foodand Drugs Administration that looks into issues of patenting andcarrying out tests on drugs to ensure that they are safe for humanuse. There are a lot of conflicting factors in this matter such asweighing between a drug’s ability to relieve pain and also itslevel of addictiveness. This regulatory authority will determine theextent to which a drug that would be addictive and such informationreleased to the public. This is where aspects of correct prescriptionof drugs will come in.

Onthe social aspect, the regulatory authority is the government. Thegovernment comes up with laws on any matter that it feels affects thesafety of food and drugs, and then it is the work of the FDA to comeup with policies to guide how these laws will be implemented.

Thereare those people who feel that compounders should be regulated justlike the pharmaceuticals and there are those who feel that thisshould not be the case. Just like Jeffrey Francer it is my opinionthat the compounder should be regulated just like other drugmanufacturers (Should FDA regulate compounders like conventional drugmanufacturers? 877). Distinguishing between traditional andnon-traditional compounders as suggested by Janet Woodcock will beimportant only to the extent that it guides the policy makers inassessing the extent of harm that a certain drug could bring if leftfor distribution. It is also important to look into the origin of thedrug as well the trend in other countries. Dr. Sydney Wolfe raisesthis concern when he asks whether the rest of the world is wrong andAmerica right (Regulators seek to curb use of addictive painkillers873).

Thecurrent regulatory framework has all it takes to ensure the safety ofdrugs in circulation. However, the bodies mandated to do this havenot fully met the criteria of procedural fairness substantivecorrectness and achievement of public policy goals. They will only besaid to have met the criteria the moment there will be no corruptionin the issuance of these drugs for distribution, the moment that thepublic will be well educated to distinguish between an advertisementmeant to lure them into using a drug and a genuine advertisement, andthe moment all compounders and drug manufacturers will be treatedequally.


PeterK., (2013). . CQResearcher,862-886.