The Food and Drug Administration (FDA) is taking what, for an agency that's generally known for its caution and under-the-radar regulatory approach, may be seen as an aggressive new tact against drug makers: Publicly calling out companies accused of delaying the entry of cheaper generic drugs to the market by preventing generic manufacturers from getting samples of expensive brand name medicines. On Thursday it posted a list of more than 50 drugs for which it says drugmakers reportedly refused to give generic drugmakers samples they need to develop copies that will eventually cut consumer prices.
"This is a great day for for patients, since the administration's list makes the definitive case why brand-name drug companies must stop blocking generic competition", said Allen Goldberg, vice president of communications for the Association of Accessible Medicines.
The Dow companies were listed among dozens of generic and brand-name drugmakers about which complaints have been filed for refusing to provide samples of their products to generic drugmakers wanting to make copies of the brand-name drugs. "The inability of generic companies to purchase the samples they need slows down, or entirely impedes, the generic drug development process - leading to delays in bringing affordable generic alternatives to patients in need". "We hope that this increased transparency will help reduce unnecessary hurdles to generic drug development and approval". Sign up today to get pharma news and updates delivered to your inbox and read on the go. Actelion received eight letters since 2013 about its pulmonary hypertension medications.
Branded companies often base their decisions to restrict access based on what they say are limitations imposed by a so-called limited distribution program or the equally arcane Risk Evaluation and Mitigation Strategy (REMS) program, which is meant to balance the risks and benefits of a given drug.
Celgene accounts for 31 inquiries from companies wanting samples of its blockbuster multiple myeloma drug Revlimid as well as its popular Pomalyst and Thalomid.
Drug companies are free to charge whatever they want for their products. Some of the products in the new list are indeed subject to those program limits - but some aren't at all, the FDA said.
For example, some companies said they couldn't share drugs because they are subject to safety restrictions.
FDA was requested by the Generic-drug companies for assistance in receiving samples of a variety of drugs from those companies, including cancer, HIV and rare disease drugs.
"I'm not looking to shame drug companies", Gottlieb said at a breakfast with reporters Tuesday.
Congress has also looked at legislation to crack down on these tactics. It was dropped from the Bipartisan Budget Act in February under heavy pressure from the brand-name pharmaceutical industry. For those that are, the FDA will review the protocol the generic company proposes to use to protect the tight distribution and write a "safety determination letter" to ensure the original drugmaker that releasing samples won't violate the REMS. Makers of the copycat drugs say that in some cases they've been unable to get samples of the drugs due to safety programs that were created to protect patients, but that have been used instead to prevent competition. Together with Novartis, the former Swiss biotech has the highest number of products - four - that generic competitors have claimed to have trouble accessing.