The rigorous review process used by the FDA makes it difficult for new generic drug entrants to be approved. Patents also give pharmaceutical companies market exclusivity for a considerable period, a period in which these companies take advantage and come up with outrageous prices considering they have zero competition.
A specific aspect to be zoomed in and addressed is the FDA’s process of reviewing generic drugs applications. The FDA ought to review its policies with respect to reviewing generic drugs but must also ensure integrity and quality of these products. It comes down to developing efficiency of this process.
Reducing the time taken for a generic product to be approved and reducing the market exclusivity period given to brand name drugs.
Though the exclusivity time given to these drugs is attributed to the intensive investment made by the pharmaceutical company over a long period of time so as to manufacture the drug, it is integral to consider that the government partly or fully finances medical research, and the development of new drugs is at times courtesy of the taxpayers money.
On this account, pharmaceutical companies whose researches on drugs were financed by the government ought not to be given a long exclusivity period, but rather, the drugs ought to be sold to the public at low rates.
In any case the price remains to be substantially high, the FDA should embrace leniency in reviewing generic products that are to the required standard.
MHAFP5032 Policy and Pharmaceutical Regulation Presentation: Current programs and Outcomes
In the recent past, other interest groups have been advocating for reduced prescription drug prices in the country.
For example, earlier in the year, some of the states embraced change in policies that now require pharmaceutical companies to be transparent to the government and the public regarding their drug pricing process.
Some of the states that first approved this legislation are Connecticut and Maryland. In the state of Connecticut, an interest group by the name Universal Health Care Foundation of Connecticut was pivotal in creating advocacy for the transparency legislation.
As a result, insures are required to give reports to the state insurance department, elaborating on drugs prices through insure rate review procedure.
In Maryland, Maryland Citizen’s Health Initiative significantly contributed to the approval of the transparency policy whereby pharmaceutical companies are to elaborate the rationale for list prices of drugs.
Outcomes associated with the approval of these legislations are promising, as this has brought a sense of pharmaceutical companies being accountable to the state governments and the general public, getting rid of the opacity of the pricing process.
In the long run, unreasonable drug prices will be challenged if the rationale behind pricing process is not justifiable. A decrease in drug prices, on account of these new policies, is anticipated, making it easier for patients to access quality prescription drugs