FDA has accelerated the approval of new drugs and devices by streamlining the development process. The process has been simplified and improved. The first step is the discovery phase which involves the research of a new drug or device in the laboratory. The second step is the preliminary research phase which involves animal and laboratory testing of the devices and drugs to find out about their safety. The third step is the clinical research phase which involves testing the drugs and devices on people to ensure they are effective and safe. The fourth step is the FDA review phase where the FDA team critically analyses all the data from the results to decide whether to approve the drug or device. The fifth step is the Safety Monitoring where the FDA monitors the safety of the drug or device during use by the public.

Fast track method fastens the expedition of drugs that treat serious ailments and cater to unmet medical needs. Breakthrough therapy is used to expedite more effective drugs than the ones available in the market. Accelerated approval is for drugs that have proven to have a clinical benefit and treat unmet medical needs(FDA, 2018). Priority review puts a time-frame of ix months which the FDA needs to decide on a drug or device.

Effects

Patients are getting access to more effective medicine than the ones previously available in the market. It has enhanced the treatment of serious sicknesses. The drugs and devices offer clinical benefits and satisfy unmet medical needs. Accelerating the approval of new drugs and devices do not allow the FDA to come up with safer and more effective drugs and devices. It also adds a lot of pressure on the FDA which is not good for work as their type of job demands a relaxed mindset.

Should the FDA adopt a liberal or conservative approach to approving medical products?

The FDA should adopt a conservative approach to approving medical products. Their core principle should be to increase medicine effectiveness and safety.Adopting a conservative approach would reduce the negative side effects of the drugs. It would also ensure the approval of highly effective medicine which meets the patient’s needs. It would save costs unlike using the liberal approach which would result in damage costs and repetition of the entire process. For instance, a patient would be afraid to use a drug that has never been used before and produced positive results. Patients are more comfortable using drugs and devices that have already given good outcomes.

Regulatory Approach Effect

The regulatory approach would use more than ten tests on animals,and the results have to be 8/10 or above. This regulatory approach would delay development and manufacturing because it involves a time-consuming process of thorough testing. The marketing of the products would be high because the drugs would be highly effective and safe.

How well have the incentives provided by the Orphan Drug Act worked?

The incentives provided by the Orphan Drug Act have worked extremely well. It has significantly increased public health value. For instance, there have been more than 450 rare drugs approved since 1983(Tribble, 2017). The prices of rare-disease drugs have in past years sky-rocketed. It has resulted in the treatment of rare disorders. It has seen the increase of treatment of cancer. For instance, in 2010, The Office of New Drugs (OND) and the Center for Drug Evaluation and Research (CDER)formed the Rare Diseases Program to support and enable the approval, regulation,development and research for biologic products and drugs for rare disorders treatment.

References

FDA. (2018). Development & Approval Process (Drugs). Retrieved from https://www.fda.gov/drugs/developmentapprovalprocess/default.htm

Tribble, S. (2017). FDA Commissioner: Are The Incentives Right For Orphan Drugs?. Retrieved from https://www.npr.org/sections/health-shots/2017/12/22/572673636/fda-commissioner-are-the-incentives-right-for-orphan-drugs