Friday, February 16, 2007

Congress looks to give FDA authority to approve biogenerics

US branded drugmakers have expressed concern about the possibility of new legislation that has been introduced by Congress that could give the Food and Drug Administration authority to approve generic versions of biologics.

'The Access to Life-Saving Medicine Act,' a bipartisan bill which is backed by a number of high-profile politicians including Hillary Clinton and Henry Waxman, would mean that the FDA would be able to decide, on a case-by-case basis what clinical trials a generics firm would have to do to win approval for biologics once their patents had expired.

Rep Waxman said the bill would "lead to healthy competition and long-term savings for patients and payers," adding that "no policy in this bill will undercut safety and effectiveness in the interest of saving money." The safety issue has been the branded pharmaceutical makers' biggest problem with the issue of generic versions of biologics and the big biotechnology firms like Amgen and Genentech have said that the treatments are highly complex and cannot be, in most cases, replicated without lengthy clinical trials.

However the cost issue is also a major factor. Express Scripts, one of the largest pharmacy benefit management companies in North America, which serves over 55 million patients, claimed that generic biotech medicines could save US plan sponsors and patients $71 billion over ten years, with $3.5 billion of the savings occurring in the first year.

It added that these medicines "treat chronic or complex illnesses that affect less than 3% of the general population," but they come with a significant price tag," as these patients account for 25%-30% of a company's overall pharmacy costs. Express Scripts added that said its projected savings figure assumes a 25% discount off the price of medicines in four categories of drugs - insulin for diabetes, erythropoietins for anaemia, growth hormones and treatments for multiple sclerosis.

Unsurprisingly, the USA's Generic Pharmaceutical Association (GPhA) expressed its "strong support" for the legislation and its chief executive Kathleen Jaeger who said "safety is and always will be our number one priority. That's why we support the approval pathway created in this legislation that gives the FDA the authority it needs to ensure safety, efficacy and timely access to affordable biogenerics."

The GPhA noted that the market for biopharmaceuticals "is growing at an astonishing rate," almost twice the rate of traditional medicines and accounting for approximately $30 billion in US sales, "yet in spite of this tremendous growth opportunity for these life-saving treatments, their high cost puts them out of reach for many Americans." It claims that treatment with Roche and Genentech's cancer drug Avastin (bevacizumab) costs $100,000 per year, while Genzyme's Cerezyme (imiglucerase), used to treat Gaucher disease, costs an average of $200,000 per year, and some patients are paying more than $500,000 a year.