FDA shames firms fighting generic competitors

Share
FDA shames firms fighting generic competitors

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.

Share

Advertisement

Related Posts

Russian ex-spy Skripal discharged from hospital
Meanwhile, Britain's Metropolitan Police said that the investigation into the incident was ongoing. Skripal is a retired military officer formerly of the Russian GRU, or military intelligence. "Mr.

Blac Chyna's Assistant's Death Could Mean A Huge Lawsuit For Her
Hernandez suffered a mind bleed in December 2017 and her being pregnant was allegedly terminated that month, in response to the GoFundMe web page.

Google One: Google Drive cloud storage gets a new name, cheaper prices
Also, access to extras from other Google products, like credits on Google Play or deals on select hotels found in Google Search. Google hasn't shared what the pricing structure will be for shared plans but we'll be keeping an eye out for updates.

Nokia X6 could be made available outside China
HMD has exclusively made this device available in China and we may see its global launch after all, as reported by GSM Arena . Screen: a notched 5.8-inch FHD+ (2280 x 1080) display , 19:9 aspect ratio 2.5D display , Corning Gorilla Glass 3 protection.

Judge denies Trump bid to stay Zervos defamation case
Allred said at the time that her withdrawal had "nothing to do with the merits of [Zervos'] case against President Trump ". Zervos has said those denials amounted to defamation and that diners avoided her restaurant after she was branded a liar.

Underdog Celtics ready to take on LeBron, Cavs in Game 2
Offensively, the Cavaliers rightly tried to exploit Love's low-post mismatches against smaller players in the second half. In Sunday's Game 1 of the Eastern Conference finals against the Celtics , LeBron James had an outing to forget.

Testing Stock Performance of - NXP Semiconductors NV (NASDAQ:NXPI)
On average, analysts expect NXP Semiconductors to post $7 EPS for the current fiscal year and $8 EPS for the next fiscal year. Shares of NXP Semiconductors traded down $1.97, reaching $106.87, during midday trading on Thursday, MarketBeat.com reports.

China drops anti-dumping probe of USA sorghum imports
Beijing still threatens to slap aggressive 25 percent tariffs on a swathe of USA farm goods, including sorghum and soybeans. Shipping containers are seen at Nansha terminal of Guangzhou port, in Guangdong province, China, June 14, 2017.

Reasons Why season 2
Epsom Girls Grammar School sent a note out to parents warning them the show starts screening on Thursday, NZME reports. TSPN concurs with other mental health experts that teenagers should watch this show with a parent or guardian present.

Steam Link beta has landed on Google Play
The Steam Link app also works with Android TV set-top boxes, providing it's connected to the same router as your PC. Then you can play PC games from your Android device, assuming the network connection is fast enough.

© 2015 ExpressNewsline. All Rights reserved.