Concern over the Decline in New Drugs


PureInsight | January 13, 2003

[] The Washington Post published an article on November 18, 2002 titled "Decline in New Drugs Raises Concerns–FDA Approvals are Lowest in a Decade." Although drug companies spent billions of dollars on research and the FDA has spent a large amount of money upgrading its ability to approve new drugs, the number of new drugs that went on the market in 2002 was the lowest in ten years. The decline of "Priority" drugs and "New Molecular Entities"(NMEs) are the most notable.

NMEs include those chemical compounds that have never been used in medicine. Their number has been considered a major criterion for the development of the drug industry. In 1996, there were 53 NMEs approved. In 2001 there were only 24. In the first nine months of 2002, only 11 were approved. Priority is a category of drugs that the FDA considers most likely to be a major breakthrough or life saving. In 1997, there were 32 priority drugs approved, while in 2001 there were only 6.

However, the annual funding on new drug research by drug companies tripled compared to that of ten years ago. The FDA also obtained funding to streamline the procedure for approving new drugs. However, applications for new drug approval by drug companies still dropped remarkably and the working cycle for FDA approval of a new drug has become longer.

What has led to the decline in the number of new drugs? The FDA has become stricter with the approval process due to the serious side effects caused by some approved drugs. This has become a very hot topic.

The management of major drug companies believes that the development of new drugs is declining because the drug industry is going through a transition from conventional chemical technology to more advanced biotechnology. About one hundred new drugs produced by biotechnology are in the final stages of clinical trials. They also believe that the FDA became more cautious since ten new drugs were withdrawn due to safety concerns from 1998 to 2001. Although FDA officials deny there was any problem with their approval process in the 1990s, they do acknowledge that they are more cautious of approving new drugs due to the problems caused by some new drugs in recent years. FDA officials believe that the decline of newly approved drugs is caused by a decline in the number of applications from drug companies. Drug companies complained that more safety experiments required by FDA has raised their cost. Consequently, many companies decided not to apply.

As an impartial third-party observer, Kenneth Kaitin, Director of the Drug Development Research Center in Tufts University, believes that the caution of the FDA might have played a role in the declining number of new drugs, but he does not believe it is the major factor. He believes that the true reason is that 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 FDA has its reasons for being more cautious in granting approval for new drugs. Even for those drugs already approved and sold in the market, many had been found to be more harmful than beneficial. For example, some drugs for arrhythmia were found to cause arrhythmias and death. Drug companies are traveling a difficult road. They work very hard to develop new drugs. But sometimes the effect of a proposed new drug is harmful. Sometimes, one might experience positive effects of a drug in the short-term, but in the long term, the negative effect is found to outweigh the benefits. To make matters worse, after trying very hard to develop a new antibiotic, resistant bacteria strain appear shortly afterwards. Perhaps the wise person who wishes to remain healthy should seek some avenue other than the products of chemical laboratories that had no previous existence in nature, are not effective over the long term, upset the body's balance, and are often found to engender life-threatening side effects.

Translated on December 30, 2002 from

Add new comment