Biotech firms throughout the nation, and especially in San Diego, have greatly benefited from increased speed and more efficient processes in getting drugs approved.
That’s according to a Food and Drug Administration official who was in town May 23 to announce the results of a study that shows the agency is moving much faster on drug reviews, much to the satisfaction of drug makers.
Linda Suydam, senior associate commissioner with the FDA, sat for an exclusive interview with the San Diego Business Journal during her trip to San Diego to announce the results of a nationwide survey of biotech leaders conducted by UCSD Connect and PricewaterhouseCoopers LLP in cooperation with the FDA.
It was the third survey of the biotech industry sponsored by Connect. It was conducted in 1999 and followed up on two earlier studies in 1995 and 1997. The final results from the 1999 survey were released May 23.
The FDA has made significant improvements in several key areas when dealing with biotech firms, including improved communication with sponsors, faster response time for inquiries by sponsors, increased contact between FDA reviewers and sponsors, and overall guidance, according to the study.
Areas that continue to need improvement include continued data requests from the FDA that lack clarity, the level of technical knowledge of the FDA reviewers, and the negative effects of constant FDA personnel turnover on the approval process, the study said.
The improvements in communications at the FDA have, in turn, led to quicker approvals for pharmaceuticals submitted to the agency , an area not covered in the study.
Susan Cruzan, spokeswoman for the FDA, said that in 1999, the “median total review time” for all new drug applications was 12.0 months , down from the median time of 16.5 months in 1995.
For “new molecular entities,” or applications for approval of an entirely new class of drugs, the median total review time in 1999 was 11.6 months , down from 15.9 months in 1995.
In the case of breakthrough drugs, some of these got approval in as little as six months, Suydam said.
That’s a tremendous benefit to local biotech firms. Most of the companies here are fairly small, and as such are “betting the farm on only one product,” said Terry Bibbens, a former Connect official and now a small business advocate with the U.S. Small Business Administration.
‘Valley Of Death’
“At large companies, while you’re waiting for the product’s approval you can assign your researchers to another project,” Bibbens said. “If you’re a tiny biotech company, like we have in San Diego, yours is a single-product company. You must keep that team intact, usually with venture capital money, while you’re going through the review process. And that becomes the Valley of Death for a lot of companies if the process goes beyond the normal time.”
Several recent changes helped make the improvement possible, said Suydam, including passage in 1992 of the Prescription Drug User Fee Act, which charges pharmaceutical companies a fee for the review of their products.
The $152 million raised each year goes toward hiring hundreds of additional reviewers, which in turn helps speed the drug approval process, she said.
Previously, the FDA didn’t have enough reviewers to handle the workload, and the review process got bogged down, Suydam said.
The second change was the 1997 passage of the Food and Drug Modernization Act, which changed the mission of the FDA. In addition to protecting public health, the agency is now also charged with promoting public health, and getting drugs to market as quickly as possible, she said.
Reviews Standardized
Another change is that the FDA has established standardization guidelines for both companies and FDA reviewers, so all parties know what’s expected from them before submitting drugs for approval.
Previously, there was no standardization of the review process, wasting valuable time as companies kept having to reinvent the wheel with each submittal.
Another improvement: FDA employees are encouraged to take professional development courses, so they stay up-to-date with changes in drug research and technology, Suydam said.
The increased speed and relative ease in approving pharmaceuticals has had a notable effect, Bibbens said.
Companies that used to go overseas to obtain approval for their new medications now are increasingly choosing to get their initial approvals from the FDA, allowing U.S. patients to reap the benefits of their research first, he said.
Suydam is quick to stress that although the time it takes to approve new drugs has been shortened, the procedures are just as rigorous. There are no shortcuts or easing up on the approval process, and approved drugs continue to be reviewed once they are on the market, she said.
Suydam acknowledged some drugs might prove to have previously unknown dangerous side effects, which might not be found before approval under any review process.
Rezulin, for example, was approved in 1997 as a diabetic drug under the previous, more lengthy approval period, but was recently Some media outlets have been “beating up on” the FDA over its approval of Rezulin, and Suydam imagines similar attacks will occur in the future now that the review process has been streamlined. But she stressed shorter review times does not equal greater risk.
In fact, patients benefit overall from the faster approval process, Suydam said.
“The end result is to get products to people that need them, particularly life-saving products, where if they didn’t have this product, we would either have more deaths or more injuries. So you really want to reduce the number of people who are suffering because there is no product available to them,” she said.
Suydam noted there is still room for improvement. The FDA’s entire budget is $1.2 billion, while the National Institute of Health recently got a budget increase of about $2 billion , from $14 to $16 billion.
The increase in NIH money was designed to encourage the research and development of new drugs, but the FDA’s budget for reviewing these new drug applications remains constant. Unless that changes in the future, there is a chance that the FDA review process could bog down again.
“It’s like a fire hose coming down through a straw,” she said. “There’s going to be a break somewhere.”
