Fifteen of twenty-two HINJ companies responded to the survey, which targeted functional area, occupational title, educational
level, and degree, while data were collected on numbers of employees, job openings, recent hires, and employment projections.
Structured interviews were conducted with human resources managers as well. The full report may be found at
http://www.hinj.org/UploadedFiles/HINJ_workforce_cond.pdf.
-Angie Drakulich
DRAFT GUIDANCE
FDA Issues Draft Guidance for Labeling Prescription Drugs
Rockville, MD (May)—The US Food and Drug Administration (FDA) issued a draft guidance "Labeling for Human Prescription Drugs—Determining Established
Pharmacologic Class for Use in the Highlights of Prescribing Information."
The guidance is meant to help applicants and review staff in FDA's Center for Drug Evaluation and Research "determine when
a drug belongs to an established pharmacologic class" and "how to select the appropriate word or phrase that describes the
pharmacologic class for inclusion in the Indications and Usage section of Highlights of Prescribing Information of approved
labeling."
According to a final rule published by FDA in January 2006, a drug that is a member of an established pharmacologic class
must have the name of the class and the drug's indications clearly labeled under the Indications and Usage section of Highlights.
Pharmacologic class is defined on the basis of the drug's mechanism of action (MOA), physiologic effect (PE), or chemical
structure (CS).
According to the new draft, a single drug can have multiple scientifically valid pharmacologic classes. Only the pharmacologic
classes that are clinically meaningful (that is, they enhance the ability of professionals to understand the therapeutic effects
or undesirable effects of the drug) as well as scientifically valid can be the drug's established pharmacologic class. The
draft goes on to give several examples of how to determine the correct pharmacologic class for a drug and the circumstances
in which a combination of established pharmacologic classes may be included on the drug's label.
FDA goes on to state that new drugs undergoing review for marketing or licensing approval will have their proposed established
pharmacologic class reviewed by FDA for scientific validity based on submitted evidence that supports the claim that the pharmacologic
class is known and relevant to the indication under review. If an applicant wishes to update the labeling for an approved
drug, the addition of an established pharmacologic class term to the Indications and Usage section must be proposed and submitted
in a prior-approval labeling supplement.
-Brianne Harrison
COMPANY NOTE
Baltimore, MD (May 14)—
Students at Johns Hopkins University developed a thin strip that dissolves in the mouth and is capable of delivering rotavirus
vaccine to infants. The film dissolves within one minute, prompting the baby to swallow the vaccine. The medication is coated
with a material that protects it from stomach acids but allows it to be released in the small intestine. The vaccine will
be especially useful in developing countries, where rotavirus currently causes more than 500,000 deaths per year. Current
vaccines must be chilled for transport and storage, making delivery to impoverished areas difficult and expensive. The strips
are easy to transport and do not require refrigeration.
PEOPLE NOTE
Foster City, CA (May 10)—Gilead Sciences, Inc. promoted Paul Carter to senior vice-president of international commercial operations. Carter joined
the company in 2006 as leader of Gilead's European commercial organization. He previously held various positions at GlaxoSmithKline.
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