Drug Approval Speed
By: Cohen, Placitella & Roth @ Mar 08, 2016
The speed at which the Federal Drug Administration approves the use of experimental drugs has a significant impact on the health of thousands of patients, as well as on the monetary success of biotechnology and health companies. Although there have always been concerns about the slow rate of government approvals, the FDA’s process for testing and approving drugs has recently come under closer scrutiny. This is in large part due to the recent death of the wife of Dr. Richard Pazdur, the oncology chief of the FDA, from ovarian cancer last year.
FDA Regulations and Processes in Approval of Experimental Drugs
Over the last three years, the FDA has significantly increased the speed of its drug approval process and many point to the death of Ms. Mary Pazdur as one of the catalysts for the change. Since her diagnosis in 2012, her husband, Dr. Pazdur, has showed a willingness to move much more quickly in approving treatments that were previously considered too risky.
While many applaud Dr. Pazdur for the changes, others express concerns that emotions have led to a bypassing of important safeguards. Since Ms. Pazdur’s diagnosis in 2012, approval for experimental drugs has been faster than ever before, although the process is still years long, requiring discovery and testing processes before a formal application can even be filed with the FDA. However, the average decision time on drug approval has decreased from six to five months. For instance, last year, Dr. Pazdur approved a drug for use against ovarian cancer that an advisory panel had previously voted against, 11-2.
But emotion may not be the only reason behind the increased speed of approvals. Indeed, the same year that Ms. Pazdur was diagnosed, Congress also passed a law that gave the FDA additional funds and the ability to work more closely with drug makers. In addition,, significant advances were recently made in the area of genetic research that made many medications not only more effective, but also easier to test.
But there is legitimate concern that Dr. Pazdur’s emotional experience with his wife’s illness has affected his policies. After his wife suffered increased blood pressure, fatigue, and heart swelling due to her consumption of an experimental drug during a clinical trial, Dr. Pazdur began pushing for better research into the side effects of such drugs. Rather than having doctors assess the toxicities of the drugs, the FDA will now begin asking patients to assess the side effects that they experience.
Drug Approval Speed and Personal Injury
Due to the increased speed at which experimental drugs are currently being approved, many are concerned about the thoroughness of the drugs’ testing. For instance, many fear that drug companies will try to conceal the dangers of their products in order to take advantage of the government’s new policy of increased approvals by hastily or improperly testing their own products.
Additional concerns exist in regards to the possible side effects of experimental drugs. While Dr. Pazdur has indicated that he will push for a new focus on side effect identification, the number of drugs going through the approval process and the machinations of drug manufacturing companies may still lead to the overlooking of serious side effects by the FDA.
Improper testing and unknown side effects can have serious consequences on the health of cancer patients, leaving many medical professionals and drug manufacturers open to personal injury lawsuits which would enable the victim and his or her family to recover monetary damages for their suffering.
Call an Attorney Today
If you or a loved one have been diagnosed with cancer and were injured by the use of an experimental drug approved by the FDA, you may be able to recover damages for any harm suffered. Please contact the law firm of Cohen, Placitella & Roth, P.C., for a free consultation.
