The U.S. Food and Drug Administration (FDA) has plenty of detractors. It's accused of being sluggish and too cumbersome in approving new medications, especially vitally important anti-cancer medications.
A recent analysis shows this criticism is unfounded and that the FDA is actually more efficient than the European Medicines Agency in getting drugs to market.
The FDA approved most of the new cancer medications in just six months - about half the time it took the EMA.
FDA spokesperson, Karen Riley, M.P.H. said that in terms of overall drug approval, "The FDA consistently leads the world in the number and speed of new drug approvals. Particularly outstanding is the agency's record for approving drugs for life-threatening diseases and conditions."
Changing landscape
As the biology of cancers continues to be unraveled, scientists are discovering molecules, enzymes, proteins and genes that can be specifically targeted to treat a variety of the most dreaded diseases. These discoveries are revolutionizing the oncology community and offering new hope - and life - for cancer patients.
Examples of these breakthrough medicines include Herceptin (trastuzumab), which is effective in treating breast cancer cells and Gleevec (imatinib mesylate), which has completely altered the treatment of chronic myelogenous leukemia.
These major advancements don't quell the critics. The FDA continues to be thought of as slow to respond, with an overly protective concern for safety that gets in the way of progress.
Reviewing the reviews
Samantha Roberts, Jeff Allen and Ellen Sigal of the Friends of Cancer Research in Washington, DC conducted a side-by-side comparisons of the review times at the FDA and EMA.
Only active treatment drugs were analyzed; devices and supportive care therapies such as anti-nausea medicines or pain relievers were not included.
The study examined the approval processes for 35 new oncology drugs that were approved by either the FDA or the EMA in the period 2003–2010.
Researchers looked at the time between the first New Drug Application or Biologics License Application submission to the FDA and the date of final approval. Once a medicine receives FDA approval, it can be marketed in the United States.
The European system involves two steps. Each drug must receive a positive opinion from the EMA Committee for Medicinal Products for Human Use, which the European Commission has to adopt before a medicine can be marketed.
For this study, researchers looked at how long the whole process - from initial EMA submission to marketing authorization - took.
The analysis was limited to initial approvals and didn't include supplemental applications, which are used to gain approvals for secondary or additional uses of drugs.
FDA approves more drugs faster
Of the 35 products investigated, the FDA approved 32:
- The median time of approval was 182 days
- Only three of these drugs took longer than a year to approve
On the other hand, the EMA approved 26 of the 35 drugs identified:
- The EMA did not approve nine of the 32 medications the FDA approved
- The median time for EMA approval was 350 days
- Three of the drugs approved did not receive FDA approval
Fast-tracking cancer drugs
While many cancers can be cured surgically, and some can be effectively treated with radiation and chemotherapy, metastatic cancers that have spread from one part of the body to another can't be cured medically. Life extending therapies are not available for many of these cancers.
The unmet need in treating metastatic cancers remains huge and has become a priority in the oncology field. Because of this need, the FDA has made attempts to shorten the time for anticancer drug approvals.
New cancer therapies are often given priority review ratings to take advantage of accelerated review systems. In fact, 71 percent of oncology drugs were given a priority review status and 47 percent received accelerated approval, compared to 40 percent and 13 percent, respectively, for all other drug classes.
A priority review designation is given to drugs that are expected to offer major treatment advances or to treat a condition that has no adequate therapy. The goal for priority reviews is six months, compared to the typical 10-month goal for a standard review.
Accelerated approval allows the FDA to approve a drug based on different standards such as tumor shrinkage that's considered a means for extending life.
Overcoming the traditional challenges
Methods to speed approval of cancer drugs are meant to offset the challenges presented by traditional clinical trial process for oncology drugs. These difficulties include:
- The amount of time it takes to enroll patients
- Lack of information about clinical trials
- Patients' fear of the process
- Rarity of some cancers being targeted
- Patient eligibility
As a result, the FDA has tried to give cancer drugs advantages to balance out for these other factors. At the same time, there's a delicate balance between accelerated approval and patient safety. Overall, though, the majority of cancer drugs have good safety track records.
Still, despite the priorities given these therapies, the lack of new oncology medicines can't be blamed on the review process so much as the difficulties of carrying out oncology clinical trials.
Beyond cancer therapies
FDA spokesman Riley said, "Since 2002, with the exception of 2008, the FDA has approved more original drug products, the so-called new molecular entities, each year than all the other countries in the world combined."
Continuing, she said, "For example, of 57 novel drugs approved by both FDA and EMA from 2006 through 2010, 43 were approved first in the United States. Of the 27 drugs in this group that were given priority review because of their special therapeutic value, 24 were approved first by FDA."
And with regard to cancer drugs analyzed in the study, Riley points out, "All 23 cancer drugs approved by both agencies during this period were marketed first in the U.S."
Based on these findings, perhaps the drumbeat of criticism against the FDA will be quieted.
