Extension Likely for Law Encouraging Medication Studies in Children
Only a handful of psychiatric drugs on the market has been tested for use in children. APA and the American Academy of Child and Adolescent Psychiatry (AACAP) are supporting renewal of a Senate bill that would encourage more drug companies to study drugs that may benefit children.
The Best Pharmaceuticals for Children Act (S 838), introduced by Sens. Christopher Dodd (D-Conn.) and Michael DeWine (R-Ohio) in May, would renew the pediatric exclusivity provisions in the 1997 FDA Modernization Act, which is set to expire January 2002.
The goal of the bill is to encourage drug companies to test in children drugs that the FDA considers a priority. In exchange for conducting studies, drug companies are granted an additional six-month patent exclusivity for the drug.
The FDA has developed a list of about 450 priority drugs in all classes of medications it wants tested, including 25 psychotropic drugs (see box).
Pediatric exclusivity does not guarantee FDA approval of the drug in children. It means that the company has agreed to submit the results of the study to the FDA and that the agency will make a decision based on safety, efficacy, and dosing information.
So far, only three psychiatric drugs from the list have been granted patent exclusivity for use in children since the 1997 FDA Modernization Act was implemented. These are buspirone (Buspar) indicated for anxiety, fluoxetine (Prozac) indicated for obsessive-compulsive disorder (OCD) and depression, and fluvoxamine (Luvox) indicated for OCD.
Of those drugs, only fluvoxamine has been approved by the FDA for a label change, although it is likely that the other two drugs will eventually have labeling changes indicating their use with children.
Solvay Pharmaceuticals completed its study last year of fluvoxamine in children with OCD, and in September it received FDA approval to change the drug’s label to indicate that the dose may need to be increased to adult levels in adolescents, and that girls aged 8 to 11 may require lower doses, according to the FDA.
Dodd hailed the 1997 pediatric initiative as a success when he introduced the pediatric reauthorization bill in May. “In the three years since the initiative was launched, over 300 pediatric studies have gotten under way, compared with the 11 studies conducted in the six years prior to the legislation,” Dodd said in a statement.
New pediatric information has been or will soon be added to 28 products including drugs for AIDS, diabetes, mental disorders, and asthma, according to the statement.
The bill appears to have widespread support among members of the Senate Health, Education, Labor, and Pensions (HELP) Committee, who held a hearing on the pediatric exclusivity provisions in May and will be voting on the bill soon. The HELP committee has oversight over the FDA Modernization Act, as does the House Energy and Commerce Subcommittee on Health, which also held a hearing on the bill in May.
Concerns about the costs to consumers of granting additional six-month patent exclusivity to pharmaceutical companies were raised in the House hearing, according to Mary Crosby, AACAP director of government affairs. In spite of the concerns, there appear to be enough committee members who support renewing the bill, added Crosby.
For a blockbuster drug such as fluoxetine (Prozac), the additional patent exclusivity translates into roughly an additional $2 billion in annual sales, according to a January report by the FDA to Congress. Meanwhile, consumers do not have access to cheaper generic drugs during that time, which increases their spending on the brand-name drugs by $695 million annually, states the FDA report.
Dodd and DeWine recognized that the 1997 provisions needed to be strengthened and require drug makers to pay user fees to participate in the pediatric exclusivity program. Additional provisions call for shortening the FDA labeling process from 12 to 18 months to six months, and promoting pediatric studies of drugs whose patents have expired, such as methylphenidate (Ritalin).
“Although off-patent use is a legal and accepted part of medical practice, it should not be the standard operating procedure,” AACAP noted in a statement submitted to the Senate HELP committee in May.
New provisions in S 838 would require the FDA to disseminate the results of the trials to physicians and parents quickly and establish an Office of Children’s Therapeutic Research within the FDA to track these activities, according to the bill.
“We need as much information as possible about efficacy, safety, side effects, and appropriate dosages. We are well aware that children are not just little adults, and the results of these studies clearly enhance our ability to provide the most appropriate and effective care possible,” according to David Fassler, M.D., chair of the APA Council on Children, Adolescents, and Their Families.
An Action Alert summarizing the bill and the committee hearings is available on the AACAP Web site at http://capwiz.com/aacap/issues/alert/?alerted=33104. ▪
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Published online: 20 July 2001
Published in print: July 20, 2001
Notes
It appears likely that a federal law to encourage more drug companies to conduct pediatric studies will be extended for another five years.
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