First, the good news: Scientific advances and regulatory changes in recent years have created an environment of innovation in the pharmaceutical and biotech industries that is "nothing short of remarkable," according to an annual report released by the Tufts Center for the Study of Drug Development.
Drugs for devastating illnesses such as AIDS, cancer, and respiratory disease are reaching patients much faster than was possible a decade ago. In some cases, companies and regulators have shaved years off the development and approval of breakthrough treatments.
Now, the bad news: The pace of innovation -- remarkable though it may be -- still can't keep up with the increasingly demanding business of drug discovery and development, the report said.
While treatments for some illnesses reached the market faster, drugs for heart disease, diabetes and chronic pain, among others, did not. Research and development costs increased. Biotech products, once considered quicker to develop than traditional pharmaceuticals, are no longer winning the race to market.
And, Kenneth Kaitin, the Tufts center's director, said lawmakers are likely to reverse some of the regulatory changes that helped speed drug approvals in the face of growing public concern over the safety of rapidly approved drugs and rushed clinical trials.
To make matters worse, all this is happening at a time when pharmaceutical companies are coming under increasing pressure from the public to produce lower priced drugs and from investors to turn out an ever-steadier stream of blockbuster drugs.
"The pharmaceutical and biotech industries realize they are heading into difficult territory," Kaitin said. "They are trying to achieve efficiency through better technologies, improved recruiting of patients for clinical trials, and by streamlining research. But the overall time it takes to get products to market is somewhat out of the industry's control."
Before 1992, when Congress passed an act allowing the US Food and Drug Administration to charge companies an application fee to help fund additional resources, it could take three or four years for the agency to complete a review of a new drug.
Drugs developed by American companies were often approved for use in Europe and Asia before passing regulatory muster in the United States, Kaitin said. But faced with the AIDS epidemic and other serious medical conditions, public perception of what constituted an acceptable amount of risk shifted.
With the regulatory changes in 1992 and subsequent changes in 1997, the FDA pledged to decrease the review process from three or four years to a single year for standard applications and to six months for applications given priority status.
The changes encouraged more FDA involvement in the designing of clinical studies to help companies shorten the time it takes to develop a drug and help the agency learn about the drug before the formal review process began.
Kaitin said the changes were enormously successful in speeding review times.
But he believes that the public is beginning to question whether safety is being jeopardized in the rush to get drugs to market.
Some complications are inevitable even under stringent review, Kaitin said. But events such as the recall of the diabetes drug Rezulin due to unforeseen side effects and the death of a young man participating in a gene-therapy trial contributed to the changing perception, he said.
"Certainly, the shift is going to put additional pressure on industry," Kaitin said. "If it goes back to the old days in early 1980s, when we were the last industrialized country to get new medicines, that would be a mistake. But it's up to the public to determine where the balance should be set."
And the drug industry will have to adjust to meet those demands, Kaitin said.
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