In 2014, the FDA Center for Drug Evaluation and Research approved the most drugs since 1996. The FDA approved 41 novel medications last year, 62% more than the 27 approved in 2013. The only year that topped 2014 was 1996, when 53 new drugs were approved.
The new drug approvals consisted mostly of innovative, expensive treatments where competition is limited and costs of treatment can often exceed $100,000 per patient per year. Infectious disease drugs received twelve of the approvals; cancer drugs received eight approvals; and five rare-disease drugs were approved.
Pharmaceutical-maker AstraZeneca led the way, with four approvals in 2014. However, over the past five years, the FDA has approved the most drugs from Johnson & Johnson, GlaxoSmithKline, and Roche Pharmaceuticals. All three companies have had negative press recently:
- J&J, over its power morcellators which are believed to promote the spread of cancer in unsuspecting women and for faulty hip replacements devices;
- GlaxoSmithKline, for bribing Chinese officials to boost sales and off-label marketing; and,
- Roche, for failing to report various drugs’ adverse side effects.
There was a surge in pharmaceutical and biotechnology enthusiasm in 2014, highlighted by the high number of approvals and the expansion of the financial markets in these fields. The Nasdaq Biotechnical Index and the S&P 500 Health Care Index were lifted 34 and 23 percent, respectively, last year.
Modern therapies are becoming more specialized, but it is important to note that the FDA’s regulatory process for specialized and breakthrough innovations shortens the timeline for FDA review, which can reduce the time and effort companies put into their safety reviews.
If your or a loved one suffered an injury as a result of using prescription medications and you were not adequately warned of the risks of the medication, you may be entitled to financial compensation. Lopez McHugh’s pharmaceutical attorneys are experienced in handling lawsuits against pharmaceutical companies. Contact a pharmaceutical attorney today at (877) 737-8525 or fill out a contact form on our website for a free initial consultation.
