FDA, Industry Discuss GMPs

FDA, Industry Discuss GMPs

SECAUCUS, N.J.--On May 4, the Food and DrugAdministration (FDA) went over the complicated issue of good manufacturingpractices (GMPs) with industry members attending SupplySide East here.

At the conference, which was packed with industry members with GMP concernsand questions, FDA officials reiterated the intent of GMPs: to protect consumersfrom adulterated product, to protect consumers from product that do not containwhat is on the label and to provide industry-wide standards for industry.

One of the most interesting parts of the conference that had not been widelyreleased was an economic analysis of the GMPs, in which it was reported theywould have a $100 million impact on the economy, but in the long run, thepractices would save $105 million in illness costs and $3 million in recalls(both numbers were based on pre-GMP statistics).

Costs to industry to implement GMPs differed among business types; for verysmall businesses (20 and fewer employees) the cost would be $38,000 per year,for small businesses (20 to 500 employees) $61,000 per year and for largebusinesses $47,000 per year. According to FDA, very small businessescharacterize the industry, which has a mean number of 8 employees per company.

Of course, these numbers were just estimates. The agency stated companiescould help with finalizing the rule by estimating how much it would take,realistically, to become GMP compliant. Be aware, though, that information sentto FDA will be made public, due to the Freedom of Information Act. The agencysuggested estimating numbers that should remain private, such as revenue andprofit.

Another large industry concern addressed by FDA was costs associated with GMPcompliance, which could put many companies out of business--especially thosefirms making less than $500,000 per year. FDA stated that it had extended itsdeadline for small businesses to become GMP-compliant--three years followingfinal rule publication--to help with this issue.

During the Q&A session following the presentation, good questions wereraised, such as if FDA would consider making vitamin products have mandatoryexpiration dates since vitamins degrade quickly ("This is a good questionto send in for comment," FDA said).

Attendees were glad to have put in a Sunday appearance for this forum."I was pretty interested in how GMPs affect foreign firms," saidSheldon Baker of Clovis, Calif.-based Baker-Dillon Public Relations. "Itwas very informative, and even though some questions were not answerable, thesession was still informative."

Leo Cullen, executive vice president of Fairfield, N.J.-based Buckton ScottNutrition Inc., stated, "I thought it was helpful and gave good informationfor small companies."

Written comments will be received for 90 days after the publication date(March 13) of the proposed rule in the Federal Register, and may beaddressed to Dockets Management Branch (HFA-305), Food and Drug Administration,5630 Fishers Lane, Room 1061, Rockville, MD 20852. As Karen Strauss, consumersafety officer in the FDA Division of Standards and Labeling Regulations and aspeaker at the conference, stated, "We've asked for many specific comments,and we are really looking forward to these comments."

The conference was co-sponsored by NSF International and Virgo Publishing,the latter of which puts on SupplySide East.