Gottlieb Pushes for Generic Drug Access

Improving access to generics and battling anticompetitive measures by brand name drug companies are among the top priorities of FDA Commissioner Scott Gottlieb, MD.

Gottleib said brand name drug companies are "gaming the system" to block generic competition and vowed to change that system, according to a USA Todayarticle.

Gottlieb’s comments come on the heels of profit losses by leading generic drug manufacturers, such as Teva Pharmaceuticals, along with retailers and distributors, due to lower generic drug prices.

CVS Health said its pharmacy same store sales dropped 2.8% in the most recent quarter, negatively impacted “due to recent generic introductions”.

In addition, in its fourth-quarter revenue report, Cardinal Health said its pharmaceutical segment profits dropped 7% to $505 million, “driven by generic pharmaceutical pricing and the company’s ongoing investment in its Pharmaceutical IT platform.”

Brand drug manufacturers are scamming the system because they are not giving generic drugmakers access to drug doses for their patient safety studies, according to Gottlieb. Generic drugmakers need up to 5,000 doses to do the studies needed to prove their products are truly equivalent, he said in a meeting with the editorial board of USA Today.

Gottlieb has letters from more than 100 generic drugmakers, complaining about access to the drug doses, along with restrictive contracts that prevent distributors from selling to generic companies. He said FDA plans to release these letters about unfair practices to the public.

"He's trying to do what he can in shaming them and to push every lever he can, but he will probably need congressional action to deal with it once and for all," said David Mitchell, founder of Patients for Affordable Drugs.

The CREATES Act of 2016, pending in Congress, should increase access to the samples.

“Without access to these samples, generic and biosimilars approvals are blocked and patients are left without access to more affordable medicines,” a coalition of retailers such as CVS Health and groups such as AARP, wrote in a letter to Congress in support of the Act. “The CREATES Act would give generic and biosimilar manufacturers a clear and efficient pathway to combat these bad actors.”

Abusing the patient safety programs to prevent generic competition costs the health care system around $5.4 billion annually, including $1.8 billion to the federal government, according to the letter.

Meanwhile, Gottlieb praised FDA's record one hundred generic drug approvals in July. He hopes to cut the review time for generic drugs from 4 years to about 10 months.