PRESIDENT’S UPDATE MARCH 2020
The FDA’s Office of Generic Drugs (OGD) recently released their 2019 Annual Report highlighting some of the accomplishments for the year.
With all of the talk of controlling rising drug costs, it would be a good idea for some of the politicians to get a better understanding of how generics pieces fit into the puzzle. In 2019 the FDA approved 1,014 final or tentative approvals. That’s almost four (4) approvals every business day of the year. Of these approvals, 110 of them were for complex drug applications and 107 were first time generic approvals.
Some of the big approvals to hit the market were generic Advair with generic sales estimated to reach over $650 million at a significant discount from the brand. Generic Delzicol hit the market in 2019 with sales estimated at over $100 million. Plus generic Lyrica was approved and launched by up to 10 manufacturers. Pfizer, who had reported past sales of close to $4 billion annually saw almost 90% of their market go to the generics. Prices fell from almost $7/does to approximately .10 cents.
So, hopefully the politicians understand that when they talk about drug costs increasing, and yes, sometimes even generics increase, overall generics continue to save consumers billions and billions of dollars each year. Don’t focus on the few that go up in price when market conditions change but rather look at the hundreds of generics that decrease on almost a daily basis.
The FDA has been in close contact with many generic companies to understand how the coronavirus (Covid-19) outbreak in China will impact the pharmaceutical market in the US this year. Based on some of their findings they are already reporting that they anticipate disruptions of finished goods coming from China as well as active and inactive ingredients of which China is a major supplier.
FDA has also announced that they have stopped pharmaceutical plant inspections in China and will rely on the company’s compliance history to determine whether drugs are safe for importing into the US. Given the compliance records of some, I find this a little frightening. We’ve been in touch with many of our suppliers on this issue and have been told that depending on the length of the outbreak they are expecting disruptions and possibly shortages over the next few months.