Sustained Innovation Generated by the Biopharmaceutical Research Sector

Study Shows Steady Stream of Innovation in Drug Discovery

08.09.13 | By Gretta Stone

In case you missed it, a blog post and article published in Health Affairs by FDA officials earlier this week highlights 25 years of steady and sustained innovation generated by the biopharmaceutical research sector. The study finds about 40% of drug approvals in the last decade have been first-in-class treatments - a remarkable number considering the hurdles inherent in developing a drug that works completely differently from any other approved medicine.  On account of this continued stream of medical advances – which in recent years has included new treatments for diseases like cystic fibrosis, lupus and lung cancer -- the lead author from the FDA concludes that there is "no evidence of an innovation gap in drug discovery." 

Measuring innovation is a difficult task and, as the researchers point out, looking at first-in-class and priority-review status captures many but not all advances. Additional medicines within a class often offer patients and physicians needed options to find the treatment that works best for their individual needs. In some cases, for example, new medicines in a class can help patients better adhere to their prescription drug regimen, particularly if those new medicines need to be taken only once daily rather than multiple times a day.                                                       

It's also difficult to predict which medicines will prove to be most beneficial for patients over time. When clinicians use medicines in practice and researchers continue to study them in the years following initial FDA approval they are able to refine and potentially uncover additional uses, benefits and sometimes risks. Therefore, the full innovation potential of a drug may not be apparent for many years. 

Biopharmaceutical researchers are working to turn scientific opportunities into the most innovative medicines possible. In fact, a study released by PhRMA earlier this year found that 70% of drugs in the pipeline are potential first-in-class treatments. Many of those will not make it all the way through the gauntlet of testing to reach approval and many are competing to be the first in a given new class. The high percentage indicates the sector's focus on pursuing promising new scientific avenues. 

Bringing new, innovative classes of medicines -- as well as improved and varied medicines within an existing therapeutic class -- to patients in need is the goal of researchers working together across the biopharmaceutical research ecosystem. The FDA's analysis reflects a high level of consistency and success in accomplishing this goal despite the complexities and hurdles inherent in the drug development process.

Looking ahead, fostering these advances and accelerating progress will require thoughtful, science-based policies to turn unprecedented potential into innovative medicines for patients. 


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