CURATIVE TECHNOLOGIES' PROCUREN PROMOTIONS SUBJECT OF WARNING LETTER concerning the company's autologous platelet-derived wound- healing product. "Labeling and promotional material for Procuren is false and misleading in that the product is an unapproved new biological drug, the efficacy of which has not been established," the April 30 warning letter states. CTI said it is in the process of formulating a response to the agency. While the warning letter calls Procuren an unapproved biologic, the letter is aimed purely at specific violative promotional materials used by CTI and does not indicate that the company will be required to submit a PLA, FDA said. CTI said it will meet with the agency soon to identify which promotional practices are the subject of the letter. CTI has sold Procuren since 1988. The company maintains that Procuren, which is produced from patients' own blood, falls outside of FDA regulatory jurisdiction because it is not shipped across state lines ("The Pink Sheet" July 1, 1991, T&G-10). A June 28, 1991 prospectus for CTI's initial public offering states that "the production of Procuren includes the use of other components which are shipped in interstate commerce" and acknowledges that "any change in interpretation of current law or any change in the FDA staff's position" would harm the company. It is possible that the status of such ex vivo products may change. The Center for Biologics Evaluation & Research is reviewing the regulation of products derived from patients' own tissues. As one outcome of that review, the agency could choose to interpret the meaning of interstate commerce more broadly to include any out-of-state ingredients added to patients' manipulated tissues. The CBER review includes genetic therapy products, for which the division plans to issue a statement for public comment by the end of 1992 ("The Pink Sheet" Jan. 20, p. 11). FDA's letter also contains warnings concerning CTI's failure "to register all processing centers and blood collection facilities" and the fact that some patients giving blood were tested for donation criteria "up to 21 days prior to the date of actual donation." CTI said it will fully comply with these regulations. CTI operates 37 "Wound Care Centers" as joint ventures with hospitals across the U.S. and plans to open another eight centers in the next three to six months. Each WCC is capable of creating Procuren, a blend of naturally occurring growth factors, out of a patient's own blood platelets. Procuren is applied topically to chronic nonhealing wounds, such as those found in diabetics and venous stasis ulcers. CTI charges hospitals a one-time startup fee of $50,000 for a WCC and approximately $100,000 a year to keep the clinic open. In addition, hospitals must pay CTI a flat fee for Procuren. Treatment costs for Procuren alone average $4,000 per patient. Only half of the cases treated in Wound Care Clinics need Procuren; the centers also provide surgery and conventional wound healing methods, CTI said. Because Procuren is not approved by FDA, some third party payers regard Wound Care Center treatment as experimental and are unwilling to reimburse hospitals for its cost, CTI said. CTI is working to get full reimbursement for the WCCs, citing the centers and the use of Procuren as "a cost-effective alternative" to conventional wound healing techniques. CTI said it has conducted studies showing that WCC treatment reduces incidence of hospitalization, length of hospitalization and proportion of amputations, and increases the proportion of wounds healed. CTI also has a centrally-produced homologous wound healing product in development, which the company says will enter a late Phase II trial involving approximately 200 patients in the near future. CTI is waiting for a December 1990 FDA clinical hold on the product to be lifted. The company said it is near the end of negotiations with the agency over trial protocols and assays to assure consistency of different lots of the product. According to CTI's stock prospectus, a four-center dose-ranging study of 78 wounds found that 80% of wounds treated "with the most effective concentration" of the homologous growth factors healed, compared to 29% of wounds treated with placebo.
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.
Davis, a former FDA team leader in the Division of Psychiatry Products, rejoins the agency from the Usona Institute, which develops psychedelics. His background aligns with Commissioner Martin Makary’s goal of seeing new treatments approved for post-traumatic stress disorder.
As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.
