(a) Infant botulism is an acute, life-threatening paralytic disease of babies caused by a potent bacterial neurotoxin.
(b) Half of all cases of infant botulism in the United States occur in California, where the causative bacterial spores are known to be highly endemic. In any given year between 30 and 50 infants with botulism are hospitalized in California, thus qualifying infant botulism as an “orphan disease” as defined by the federal Orphan Drug Act of 1983 (P.L. 97-414, as amended).
(c) The cost of hospitalization of these afflicted babies for the five years 1988–92 were approximately fourteen million dollars ($14,000,000). Over two million seven hundred thousand dollars ($2,700,000) of these costs were paid by the State Department of Health Services through its Medi-Cal and California Children’s Services programs, while over one million four hundred thousand ($1,400,000) of these costs were absorbed as operating losses by California hospitals.
(d) Hospital stay for these critically-ill infants averages five weeks and costs approximately seventy thousand dollars ($70,000) per case. In 1992 a single case was hospitalized over six months at a cost in excess of five hundred five thousand dollars ($505,000). In 1988 a single infant was hospitalized for 10 months at a cost of over six hundred thirty-five thousand dollars ($635,000).
(e) In an effort to reduce these costs, the State Department of Health Services began in early 1992 a four-year clinical trial of a potential new medicine, human Botulism Immune Globulin (BIG), specifically designed for the treatment of infant botulism. The funding for this clinical trial is being provided by the United States Food and Drug Administration.
(f) As defined in the federal Orphan Drug Act, the State Department of Health Services is the official sponsor of BIG. As such, the department is responsible for providing and distributing an ongoing supply of BIG to infant botulism patients nationwide if the clinical trial shows that BIG is safe and effective treatment for infant botulism. The clinical trial is expected to end in 1996.
(g) If human-derived BIG proves to be effective, then physicians can choose to use it to treat foodborne botulism and wound botulism, rather than using the existing horse-serum-derived botulism antitoxin, which has serious side effects. Foodborne botulism and wound botulism also qualify as “orphan diseases” under the federal Orphan Drug Act.
(h) Other scientific evidence indicates that infant botulism and related illnesses may be responsible for one of every 20 sudden infant death cases in California. More sudden infant deaths occur in California each year than in any other state.
(i) The Legislature finds and declares that the enactment of this article is necessary for the protection of the public’s health, investigations and further research into the optimal medical treatment of infant botulism, including product improvement of BIG, and into the causes and prevention of infant botulism and related sudden infant death cases, and providing expert medical consultation for the care of infants with this disease.
(Added by renumbering Section 330.10 (as added by Stats. 1995, Ch. 674) by Stats. 1996, Ch. 1023, Sec. 117. Effective September 29, 1996.)