Consumer Drug Safety

2014 New Drug Approvals At 18 Year High

February 3, 2015 – 2015 is predicted to be a banner year for the medical research industry following a strong and innovative 2014. This past year was the best in the industry since 1996 and included FDA approval for 44 drugs. AstraZeneca led the way with four approvals among competitors that included Pfizer, Lilly, and Johnson & Johnson, the leader for the previous five years. Drugs intended to treat infectious diseases experienced the greatest success with 12 approvals and included medication for fungal, viral, bacterial, and parasitic infections. Cancer drugs had the second highest number of approvals with eight.

Unfortunately, with the surge in new developments and the potential for these drugs and devices to be rushed to market, consumers could be at risk. In the past, when products were rushed to market, patients and doctors felt ill-informed and many suffered dire health consequences as a result of using products they did not fully understand. Changes in the industry are allowing manufacturers to focus more on non-drug technologies, which could ease some of the concern, but it is still important to proceed with caution.

Changes in the Pharmaceutical Industry

Despite the success of 2014, pharmaceuticals are no longer what it once was. During 1996 and 1997, drug development was the dominant source of innovation in the medical industry. The recent decline was due to the quality of the drugs that were coming to market, as well as improvements in overall treatment of diseases. Cancer remission rates are high and hepatitis can be cured. New non-drug technologies are transforming treatment and progress is being made with tissue engineering, CAR T-cell, gene editing, biochips, bioprinting, and synthetic biology.

Experts believe this puts the medical research industry on the brink of one of the most innovative ages to date. Leading innovators are the ones predicted to do the best during this renaissance. If they are willing to look toward new developments instead of staying in their comfort zone concerning drug research and development, they are likely to fare well. Novartis, Johnson & Johnson, GlaxoSmithKline, and AstraZeneca are expected to be the leaders as the industry begins to change.

Some predict corporate attitudes are changing in the pharmaceutical industry, which is a good thing considering the damage that has been done. In addition to the changes in treatment developments, mergers in the industry have cost shareholders a lot of money. Additionally, drug manufacturers are facing hefty lawsuits in relation to many of their products. Many in the industry are looking for safer ways to provide products to consumers while still capitalizing on the most cutting-edge developments.

Breakthrough Therapy Designation

The FDA’s role in re-energizing innovation in the industry cannot be overlooked. Something known as Breakthrough Therapy Designation (BTD) is a regulatory innovation that changes the research and development process. It shortens the timeline and reduces the budget of clinical research to the point there is no denying it as the most profitable option for drug companies.

It took less than two month for the FDA to grant 68 BTD approvals in the last two years. No longer are drug companies boasting of their ability to work with “proven modes of action.” Instead, they are pursuing unproven horizons, using BTD approval for as many of the drugs in the company’s pipeline as possible. This could mean tremendous growth for the pharmaceutical injury and major progress in terms of treating disease, but it can also put consumers at risk if there is a rush from the very start of the process and products are rushed to market too quickly.

What does this mean for the average consumer and his or her health? The changes are both positive and negative. While new innovations will lead to better treatment, a rush to market could cause more harm than good. On the other hand, pursuing tracks that do not include quick-fix drug technology could lead to a brighter, more promising medical environment.

Show Sources
  1. http://www.forbes.com/sites/bernardmunos/2015/01/02/the-fda-approvals-of-2014/
  2. http://www.reuters.com/article/2015/01/01/us-pharmaceuticals-approvals-idUSKBN0KA1GC20150101
  3. http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm341027.htm