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BioPharmaceuticals: Improving Patients’ Quality of Life


When one thinks about the global economy, the biopharmaceutical industry may come to mind as one of the industries in which the U.S. is an unquestioned global leader. That assertion is, in fact, true. Of the 5,400 medical compounds under development worldwide, about 3,400 of them are being developed here, according to PhRMA.

More than 810,000 people work in the U.S. biopharma industry. Through their efforts, millions of patients enjoy healthier, more productive and fulfilling lives, with hope for a brighter future. Encouragingly, the mortality rate for heart disease, HIV/AIDS, childhood cancer and a host of other conditions have improved, with medications playing a key role.

R&D lies at the heart of that progress. Members of PhRMA invest about $48 billion per year in R&D, up from $8.4 billion as recently as 1990. One-fifth of all private-sector R&D in the U.S. is conducted by biopharma companies, according to the National Science Foundation, more than any other single industry.

The average cost of developing a new drug (including the cost of failures) is about $1.2 billion, a process that often takes 10 to 15 years. For every compound that ultimately receives Food and Drug Administration (FDA) approval, typically five to ten thousand other compounds will have been considered.

In 2012, the FDA approved 43 new drugs, the most in 15 years. These drugs treat such conditions as skin cancer, leukemia, cystic fibrosis, respiratory distress syndrome, and tuberculosis, among others. Thirteen of the approvals were for orphan drugs, which treat rare diseases.

Once a drug is reviewed by FDA scientists and approved, it can be introduced, manufactured, and marketed. Manufacturing facilities must be designed, constructed, and maintained to the highest standards, as required by the FDA.

Many physicians, patients and policy advocates are continuing to urge the FDA to streamline the approval process further, as some drugs are now introduced first in Europe, where regulatory hurdles are perceived as less time-consuming.

While improved patient outcomes lies at the heart of this Great Manufacturing Story, the industry’s economic impact is part of the story, as well. Jobs in the industry, ranging from Ph.D. scientists to lab technicians to marketing representatives, pay about twice the national average. Those 810,000 employees, in turn, generate economic activity in their own communities, supporting a total of 3.4 million jobs, according to PhRMA. Battelle estimates the overall economic impact of the industry is about $790 billion per year.

With increased understanding of genetics, the future looks brighter than ever for innovative new treatments. To ensure that medications continue to be developed, and that the U.S. retains its leadership position in the industry, the U.S. will need to maintain a framework that balances the cost of innovation and the affordability of treatments. The U.S. will also need to ensure that our education institutions are providing enough graduates with strong backgrounds in sciences, math, engineering, and technology, to ensure these jobs don’t gravitate to other nations.