NEW YORK (GenomeWeb News) – The Genetics and Public Policy Center at Johns Hopkins University has been awarded $750,000 from the Pew Charitable Trust to conduct studies of what, if any, steps should be taken toward creating consumer protections in relation to genetic testing.
The main focus areas for the Consumer Genetics Project will include whether or not the Food and Drug Administration should incorporate genetic testing information into drug labeling, a new point program for GPPC. The center also said that it will continue to focus on the truth of claims made by genetic testing companies, and issues surrounding genetic discrimination.
GPPC Director Kathy Hudson said in a statement that since the center began studying genetics-related policy issues "the technology and business environments for genetic testing have changed dramatically, creating new opportunities for protecting the consumer public and ensuring genetic testing quality. While we will need to continue efforts to ensure that needed and now widely endorsed regulatory reforms are implemented to ensure tests' accuracy and validity, new measures are needed to protect consumers from harm and to reap the benefits of genetic testing."
GPPC, which was established with a Pew grant of $10 million to Johns Hopkins University in 2002, said that adverse drug reactions are responsible for 100,000 deaths and over 2 million hospitalizations each year in the US, at an estimated cost of between $1.5 billion and $4 billion. But "there have been few examples of pharmacogenetic information being translated successfully into clinical care," GPPC said.
While FDA has put out guidance documents showing that it "appreciates the value of pharmacogenetics to foster its mission of protecting public health, the agency has not developed a clear pathway" to include pharmacogenetic information on labels, noted GPPC.
"We are evaluating the amount of evidence required by FDA to support labeling changes, the amount of time required to implement such changes, and the clarity of communication about the implications of the information for clinical care," added GPPC Law and Policy Director Gail Javitt said in a statement.
The center said it will continue to study the truth in advertising about genetic testing marketed directly to consumers.
Javitt said that the center has found that "companies are making scientifically unsupportable claims and consumers are putting their health and their pocketbooks at risk."
Although the Federal Trade Commission could regulate the industry, the agency "has taken no action to date on advertising claims about genetic tests," Javitt added.