Food & Drug Bulletin

Dear Reader:

In the past few months, we have seen quite a bit of personnel turnover within all of FDA's Centers and at all levels from directors to product reviewers. These departures likely stem from the induction of a new Commissioner. These personnel changes will be joined by continued policy shifts. In the area of drug review, one can expect a tightening of the scientific and regulatory requirements and a "slowing down" of the approval process due to the public criticism FDA has received on a number of recent drug approvals. For medical devices, we predict that the amount of clinical data necessary to support device marketing will continue to increase as those with medical backgrounds play a greater role within the Center for Devices. The Center for Foods will focus primarily on safety and increased enforcement, since a lawyer is now the Center Director.

The "wild ride" is far from over, however, since the next legislative session will bring us a new President and a newly-structured Congress. Will we have a new Commissioner? Tobacco controlled by FDA? A revised Waxman-Hatch Act governing brand and generic drug products? There are a lot of questions that only time can answer. In the short term, we will continue to fight the reg-ulatory battles, as always.

Sincerely,

Gary L. Yingling, Partner

Articles In This Issue

FDA ISSUES WARNING ON ARISTOLOCHIC ACID

CUSTOMS ISSUES TARIFF CLASSIFICATION AND DUTIES ON DRUGS AND FOODS

HCFA PROPOSES MEDICARE STANDARDS

M&C PREVAILS IN DOMAIN NAME DISPUTE

EC ADDRESSES FOOD PRODUCT ISSUES

FDA'S REGULATION OF COSMETIC INGREDIENT SAFETY

CDRH'S FEIGAL HEIGHLIGHTS THIRD PARTY REVIEW PROGRAM A MDMA MEETING

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