- In a letter to the Food and Drug Administration, Senator Bernie Sanders and other democrats exhorted the regulator to approve eligible applications for generic copies of Crestor, a high-potency statin marketed by AstraZeneca.
- After 12 years of marketing exclusivity, AstraZeneca's Crestor patent expires today. But the company recently sued the FDA to extend its patent by another seven years, claiming a recent label expansion for a rare pediatric use makes it eligible for further protection.
- The FDA had ruled that generic drugs could be marketed while excluding the new indication in their label. AstraZeneca claims that would cause a substantial safety risk for patients. The Democrats urged the FDA to stand its ground.
In the final analysis, this fight could become a precedent for how efforts to protect patents via Orphan Drug exclusivity are viewed by the courts and discussed in an increasingly savings-driven environment.
In the last three years alone, Crestor has generated $16 billion in revenues and remains a common choice for doctors prescribing statins. But the drug costs roughly $300 per month, according to prices listed on GoodRx.com. In their letter, the lawmakers argued that "FDA approval of the generic version of this drug has the potential to drastically reduce healthcare costs."
But the real decision will take place in court, as judges debate the safety risks involved in generics' exclusion of the newest Crestor indication.
While opining on the issue, the congressmen also rejected AstraZeneca's contention that allowing generic competition would present a safety risk to patients. They argued that the total population affected by the new indication represents a total of 300 children, versus the 20 million people who could benefit from a cheaper, generic version of Crestor.