Administrators to the Food and Drug Administration stated that heart studies may need to be conducted before they can be approved. This new policy could be a major setback for pharmaceutical companies as they try to bring their drugs to market.
An advisory panel to the FDA met on Thursday to vote on this new policy. Three quarters of panel members favored imposing a new regulatory requirement that heart studies be conducted on all new obesity drugs. Although the FDA is under no obligation to concur with the decisions of the panel, it tends to follow its recommendations.
[box type="important"]Professor Marvin Konstam of Tufts University said that obesity drugs have a history of causing heart problems. Therefore, he said that drug companies should be required to conduct heart impact tests before releasing them.[/box]
The FDA already recognizes how important it is to study the impact obesity drugs have on cardiovascular health. Orexigen Therapeutics has been trying to bring its new drug Contrave to market. If successful, Contrave will be the first weight loss drug the firm has brought to market in the past ten years. However, the FDA has forced Orexigen to put its plans on hold by ordering the firm to conduct heart impact studies before it can release the drug to the public. Orexigen will probably need at least two years to complete these studies.
Although members of the advisory panel clearly support requiring these firms to create heart impact studies, they have failed to reach a consensus on what types of studies they should conduct. Some advisers suggest that meta studies will be sufficient. However, other advisers said pharmaceutical firms should be required to conduct a full clinical analysis to assess the risks they posed to the health of these individuals.
Many firms will be significantly impacted if the FDA agrees with the panel. Some of these firms are attempting to release drugs that are expected to bring hundreds of millions of dollars in sales.
Although members of the advisory panel cite the dangers some obesity drugs pose, some skeptics don’t agree with their recommendations. They argue that obesity itself is responsible for many of the cardiovascular diseases people face every year. However, the FDA is responsible for holding companies to the highest possible standards of safety before they release any drugs onto the market.
Qnexa’s approval will be decided by the FDA this April.