 |
 |
  |
|
  |
|
  |
|
  |
|
  |
|
  |
 |
|
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Rockville, MD
Durk Pearson & Sandy Shaw (Commenters) hereby submit their second comments, on the subject of the economic impact of CGMPs for dietary supplement in the Proposed Rule. All their previous comments on the Proposed Rule both as individuals and as Joint Commenters (comments filed by Jonathan Emord, attorney), including the CGMP Economic Impact Assessment by economist Paul H. Rubin are incorporated by reference. The first page of the Sept. 3, 2003 issue of The Wall Street Journal (copy of article attached as Exhibit 1) provides an in depth analysis of the destructive economic impact of the FDA’s CGMPs for drug manufacturing, after which the Proposed Rule for cGMPs for dietary supplements is largely patterned. We have yellowed and marked a vertical line next to the sections of particular interest. The paragraph at the start of the article on the third page of the Exhibit notes: “In other industries, manufacturers constantly fiddle with their production lines to find improvements. But FDA regulations leave drug-manufacturing processes virtually frozen in time. As part of the drug-approval process, a company’s detailed manufacturing plan—and even the factory itself—must pass FDA muster. After approval, even a tiny change to how a drug is made requires another round of FDA review and authorization, requiring time and paperwork. The process discourages updating by the companies, which worry they will face a production delay that could cost them heavily.” Comment: This is identical to the regulatory plan FDA has written into the Proposed Rule, in which a dietary supplement “company’s detailed manufacturing plan—and even the factory itself—must pass FDA muster.” Moreover, the same problem of “manufacturing processes virtually frozen in time” that has made updating manufacturing processes in the drug industry so difficult and expensive will now be a problem in the dietary supplement industry. On the first page of Exhibit 1, in the second paragraph above the figure, the article notes that “The FDA counts 354 prescription drug recalls in 2002, up from 248 in 2001 and 176 in 1998. In one notable glitch, Schering-Plough Corp. recalled 59 million asthma inhalers in 1999 and 2000 because an unknown number were shipped out empty.” The next paragraph follows with: “Another measure of manufacturing shortcoming; 5% to 10% of medicine that’s produced doesn’t meet specifications and has to reworked or discarded, estimates Doug Dean, a long time industry consultant on manufacturing.” These numbers show that the drug CGMPs are not only not eliminating recalls, as promised by the FDA to dietary supplement companies who follow the dietary supplement CGMPs, but that recalls and quality problems are serious and widespread—about 2 orders of magnitude more widespread and common than current dietary supplement recalls. Compare the 354 prescription drug recalls for 2002 alone with approximately one tenth that number of dietary supplement recalls for the 10 years from 1990 to 1999. Thus, FDA’s Proposed Rule will not only subject dietary supplement companies to the great expenses of the Rule itself (see Rubin’s CGMP Economic Impact Assessment for a detailed analysis), but to the higher level of recalls and quality problems that follow. On the third page of the Exhibit, first column, second marked section, the article continues: “Current means for producing drugs are both efficient and prone to error, says G. K. Raju, an expert in pharmaceutical manufacturing at Massachusetts Institute of Technology who advises drug makers and has visited many plants. Quality testing is done by hand. Computerized equipment and robots aren’t as common as in other high-tech industries.” In the next paragraph, it notes that: “This inefficiency adds to manufacturing costs. Despite the importance of research to drug companies, the top 16 drug companies spent a startling $90 billion on manufacturing in 2001, according to an analysis of financial statements by Raymond Scherzer, senior vice president for manufacturing at GlaxoSmithKline. He says manufacturing expenses accounted for 30% of the industry’s costs, more than double the share of research and development, and almost as much as the 41% devoted to marketing and administrative costs.” Comment: These appalling manufacturing costs, in large part due to the frozen-in processes built into FDA’s regulatory regime, are imposing severe costs on drug companies, restricting the amount of research they can do, and increasing drug prices, all adverse results of regulations that will also happen to dietary supplement companies trying to comply with FDA’s frozen-in regulations for CGMPs. The bottom line of the analysis in Exhibit 1 and of Rubin’s CGMP Impact Assessment is that the FDA has proposed the same or similar failed CGMPs of the drug industry for the dietary supplement industry, and it will have the same negative economic impact on both companies and consumers. As noted in Exhibit 1, even the FDA realizes there is something seriously wrong with its CGMPs; “[t]he agency is overhauling its elaborate [drug] manufacturing regulations for the first time in 25 years.” So why is FDA attempting to impose this grossly failed process on dietary supplement manufacturers? Is it to raise prices of supplements so as to make them less competitive with pharmaceuticals? (We can understand how FDA might be more concerned with the welfare of drug companies that pay hundreds of millions of dollars in “user’s fees” to the FDA each year.) The failure of the FDA’s drug CGMPs is now a front page scandal in The Wall Street Journal; it would be arbitrary and capricious (and contrary to law—DSHEA called for CGMPs modeled after food CGMPs) to impose this failed system on dietary supplement companies. Submitted by:
|