PHARMACY

Survey sees increase in contraceptive use in women

BY Alaric DeArment

NEW YORK Survey results published in the American Journal of Public Health show that an increasing amount of women are using contraception.

The survey, led by the Guttmacher Institute, showed that between 1995 and 2002, the percentage of American women who reported using contraceptive services increased from 36 to 41 percent.

The author of the study examined the National Survey of Family Growth to study trends in the use of reproductive and sexual health services. The survey, conducted in cycles every few years by the Centers for Disease Control and Prevention, administers in-home questionnaires to women aged 15 to 44 and asks them to name any of the 13 listed services that they have received in the past year.

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PHARMACY

FDA new response procedure could confuse investors

BY Drew Buono

WASHINGTON The Food and Drug Administration’s decision to change how it responds to drug companies’ submissions for drug applications is not only affecting the companies, but investors as well, according to Reuters.

The approach could cloud a drug review process already growing less predictable as global pharmaceutical companies find less success winning U.S. approval for new products. The policy “may not give as much visibility to the direction the FDA is going,” Morningstar analyst Damien Conover said.

In the past, an approvable letter told companies their applications could be cleared if certain conditions were met. A not-approvable letter was seen as a sign of more serious problems.

The complete response letters will spell out what drugmakers could do to win approval, the FDA said.

But the agency by law must keep the letters confidential. Investors must rely on the companies, which often disclose only the type of letter received and give little detail about the FDA’s complaints. Manufacturers typically do not release a letter’s actual text.

Based on those facts, investors will now be guided by the companies as to what happens to a drug that could be a potential blockbuster on the market.

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Insmed ceo lobbies for follow-on biologics rule

BY Alaric DeArment

WASHINGTON The chief executive of a biotech company in Richmond, Va., wants to make it possible to get generic biologic drugs approved, the Washington Post reported Wednesday.

Geoffrey Allan, chief executive officer of Insmed, has been lobbying members of Congress in an effort to teach them the differences between chemical and biotech drugs. Allan hopes his company will become the first United States company to develop generic biologic drugs, also called “biosimilars.”

While the market for generic chemical drugs is expanding, there is no way to get generic biologic drugs approved. Allan hopes that Congress will change the laws to make generic biologic drug competition possible.

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