Question

Explain the FDA’s process for assessing the safety for prescription drugs and over-the-counter drugs and give your opinion the process (is it effective, should anything be changed, are there disadvantages of the current system, it is harmful).

Answer 1

Any Pharmaceutical company that wants to sell a new prescription drug will have to get approval by FDA. This process mainly includes 5 steps:

1. Discovery/concept
2. Pre-clinical research
3. Clinical research
4. FDA review
5. FDA post-market safety monitoring

Initially the company has to conduct laboratory testing of the drug on animals and once no harm is detected and definite results are obtained they can be tried on humans.After testing the drug, the drug test results along with other drug details are sent to the FDA for approval.An application form for the drug has to be submitted along with the details like: Drug tested results, description on the company's manufacturing process of that particular drug.It should also include data gathered during animal laboratory trials and human clinical trials.The form should also contain the proposed drug label designed by the company ,along with the indication, uses ,risks and side effects and directions for usage.

Followed by that the FDA reviews the drug research done by the company and checks the labeling information and description of the drug given by them.If the results show more drug benefits than risks and the manufacturing process meets all the quality control requirements ,the drug is approved and allowed to be marketed.However once marketed the FDA will continue to monitor the drug.

For over the counter drugs (OTC):The manufacturing company that wants to produce an OTC drug has to apply for FDA approval through NDA(New drug application) process or otherwise known as OTC monograph. A monograph will contain,all the acceptable ingredients, formulations,labeling and testing parameters for more than 80 therapeutic class of drugs.OTC drugs that have existing monograph can be sold without FDA review and those that do not come under the monograph have to undergo the NDA process.FDA monitors the OTC drug monographs to add certain ingredients and labelling whenever required.

The main responsibility of FDA through the approval process is safegaurding the public health.Therefore it makes sure that the pharmaceutical companies take the clinical trials in phased manner.Post-approval it is mandatory that the companies conduct phase-4 clinical trials to ensure that the drug is safe on humans , continuous monitoring will be done on the tested groups and in case of any adverse reactions the regulatory authorities are informed.

In my opinion the current standardised process works well with most of the drugs.The system currently in practice has been successful in launching a large group of drugs.The approximate time required for FDA approval is 6 months except for a few emergency medicines.However if the current system of drug approval would be streamlined to some extent it would aid in faster approval of drugs and drugs would get into the market faster.This would reduce the time ,money and resources involved in the research and developement of particular drug.

The disadvantages of the regulations followed currently are delays in the approval process, also cost involved in various phases of clinical trials.The current system of safety assessment can be harmful to human consumption if the quality checks are compromised for the sake of cost reduction.Therefore FDA must ensure that the processes are streamlined keeping in mind the cost of production and also the time involved for a drug to enter the market. Enhanced quality checks will help to cater to the patient safety needs of the consumers and will improve the overall healthcare delivery system to foster better care to the patients at all times.