FDA Commissioner Mark McClellan concedes that the agency could do a better job of enforcing its regulations and communicating with the industry to do its part in helping to improve the health of Americans.
While that likely is not new information to industry watchers, the agency has come up with a 26-page action plan that highlights steps McClellan's FDA will take to improve its efficiency, to maximize the public health impact of every FDA dollar and to get safe and effective drugs to market without forcing companies to spend years going through multiple review cycles.
According to the plan, titled "Protecting and Advancing America's Health: A Strategic Action Plan for the 21st Century," the number of truly new drugs (new chemical entities) approved by the FDA last year was 17, compared to a high of 53 in 1996. Similar declines are documented in other countries.
The FDA blames this phenomenon in part on new sciences just beginning to emerge out of laboratories, saying it is plausible that biomedical research dollars could take years to translate into drugs or biologics. "This transitional process means that it may still require some years and considerable costs before such an increase [in the number of products] occurs," the report said.
However, rising costs of product development also remain a key contributor, said the report, which quotes the commonly used $800 million figure as the amount it costs to get a drug to market. (Generally that amount includes the cost of drug failures factored in by a company.)
As part of its plan, the agency vows to use the most advanced science to help turn new discoveries into safe and effective treatments.
Under its risk management plan, the FDA believes it can do this by developing standards for such science, particularly in pharmacogenomics, gene therapy and combination devices. And as stated in the Prescription Drug User Fee Act III, the FDA plans to analyze causes for drug delays on its part, meaning determining whether multiple review cycles are necessary because the agency is failing to adequately communicate with the company representatives. (See BioWorld Today, June 13, 2002; May 28, 2002; and May 8, 2002.)
FDA's Role In Protecting Against Terrorism
Part of the FDA's approach to countering terrorist threats will involve working with industry and other government agencies to develop countermeasures using state-of-the-art science.
Since President Bush first mentioned Project BioShield in his State of the Union address in January, the FDA has been working to help develop the program and rally support for it on Capitol Hill.
Project BioShield is designed to streamline government research, create incentives for companies and give the government the ability to make products widely available in a public emergency. BioShield legislation passed in the House; the Senate version has not reached a full vote. (See BioWorld Today, June 23, 2003; May 19, 2003; April 7, 2003; and March 28, 2003.)
In his comments regarding the strategic plan, McClellan said the agency already has moved to make available safe and effective treatments for certain nerve gases and radiological agents, and has enhanced stockpiles of vaccines and treatments for smallpox and other possible agents of biowarfare.
"We realize that we can't easily solve the problem of getting safer and more effective countermeasures to the public with just grants and contracts, important as those are for promoting basic research," McClellan said in a prepared statement. "Our close work with the developers of these new products - which now requires the full-time effort of around 200 professional staff in our biologics program alone - has reminded us that proof of concept is still a very long way from large-scale production of effective countermeasures that pose acceptable safety risks."
Complex Products, Laws Make Enforcement Difficult
The FDA believes most businesses want to comply with agency rules and regulations, but often find it difficult to understand them.
To remedy that situation, the agency said it intends to develop clear, consistent guidelines and to better communicate rules with the firms it regulates.
For companies that violate the law, the agency believes that punishment based on the most effective tools available, including enforcement actions and criminal prosecutions that would stand up in court, will be the most effective deterrence.
Last year the agency hired 800 people to help in the enforcement arena. Most of the employees work in the food safety and food security area at border crossings, ports of entry and analytical laboratories. With those resources, according to the plan, the agency has quintupled the number of food examinations it performs.
The entire report is available at www.fda.gov.