Will The Pharma Industry Soon See Significant Changes?
The pharmaceutical industry considers the FDA a major roadblock. According to some, this agency impedes innovation because of its bureaucratic requirements, where pharmaceutical companies are required to spend $2.5 billion to get a study approved. Trump reportedly met with Jim O’Neill in December to discuss the position for commissioner of FDA.
In 2014 O’Neill openly criticized the FDA for dragging out the drug approval process, which according to him was not helping the manufacturers and the sick patients alike. He recommended the reformation of the agency where patients should have access to newly developed drugs and that these can be used at their own risk.
If O’Neill is elected as the new FDA commissioner, pharmaceutical companies are likely to release several types of drugs without so much of a liability on their part. Patients may be able to have access to the new drugs in question but the real question now is, will they really be doing it for the betterment of their health or will they fall trap as an experimental group for the pharmaceutical companies?
On another note, there are also those who are all for the FDA’s rules. It can be noted that FDA requires several types of testing before a drug can be approved for use. The agency pointed out that some drugs have been proven harmful for the patients such as semagacestat (for Alzheimer’s) that only made the condition worse, Plizer’s torcetrapib that increased the risk of a heart attack, and Intercell and Merck’s V710 vaccine that produced an immune response.
The pharmaceutical companies will have everything to gain if O’Neill will be chosen as the FDA commissioner. Patients who are fighting for their lives will be able to get access to experimental drugs. However, the question still remains – is it the best way to get a serious disease treated or will this increase the likelihood of fatality?