Cheap Drugs Create Quality Temptations, FDA Official Says

FDA will focus on enforcing quality standards, but remains aware of its indirect influence on pricing.

FDA may not regulate drug prices, but when generics become too cheap, it appears to at least raise some concerns among agency officials.

Richard Moscicki, Center for Drug Evaluation and Research deputy center director for science operations, said in some cases a month’s supply of a generic drug costs less than a bottle of water at a pharmacy.

Generic drug approvals are helping control prices, but if the price drops too low, then the potential for a quality lapse increases, he said.

“One of the things that we think is very important at the FDA is that the drugs that Americans get are of high quality,” Moscicki said during a Dec. 3 Georgetown University symposium entitled Fighting a Smarter War Against Cancer.

“But if there’s not enough money in it, those companies are often tempted to really cut their quality, to cut corners sometimes in the generics industry, to try and keep cutting and cutting and cutting in a pretty intense competitive atmosphere.”

Moscicki’s comments came in response to a question about drug costs and supporting innovation.

Fellow panel member Bill Chin, executive VP of scientific and regulatory affairs at the Pharmaceutical Research and Manufacturers of America, said there has to be a balance between innovation and drug access.

Chin also said PhRMA believes there already are enough checks and balances within the system.

Moscicki, who made clear that his comments were not speaking on behalf of FDA, said after the panel discussion that the agency will focus on enforcing good quality standards and that if generic sponsors are going to stay on the market, they will have to meet them.

He also said the agency is “not officially” thinking about if there are generic prices that are too low.

Drug costs have become a hot-button issue in the wake of the several recent dramatic price hikes.

Among those gaining the most attention was Turing Pharmaceuticals AG’s decision to raise the price of Daraprim (pyrimethamine) to $750 a pill after acquiring the off-patent medicine, which had sold for $13.50 a pill.

The company later lowered the price it charged to hospitals, but did not make it available to pharmacy benefit managers. Express Scripts Holding Co. then decided to encourage physicians to prescribe a much cheaper compounded version of the product instead (see related story, (Also see "Turing’s Shkreli Tussels With Express Scripts About ‘Ugly, Dirty Truth’ Of Drug Pricing" - Pink Sheet, 4 Dec, 2015.)).

While FDA has no official role in setting a drug price, it has used regulatory discretion in the wake of pricing concerns.

When KV Pharmaceutical Co., now Lumara Health Inc., gained approval for the previously compounded preterm birth drug Makena (hydroxyprogesterone) and raised the price significantly, FDA said it would not take enforcement action against pharmacies making less expensive versions of it.

The agency issued a statement more than a year later saying it may take action against high-volume compounding of the product (Also see "FDA Helps Makena With Statement Against High-Volume Compounding" - Pink Sheet, 2 Jul, 2012.).

Turing's Daraprim is the poster child for drug pricing concerns at the moment, but cancer products have attracted their share of criticism as well, from none less than Tom Brokaw (Also see "PhRMA Awards Celebrate Breakthroughs – And Get Warning On Prices" - Pink Sheet, 14 Sep, 2015.).

And the oncology community has also felt the impact that FDA's focus on product quality can create, having experienced shortages of many basic chemo drugs due to manufacturing problems (Also see "Sagent Turns Generic Injectable Shortages Into Business Opportunity" - Pink Sheet, 11 Jun, 2014.).

Alleviating and preventing drug shortages are among the efforts that FDA can take to reduce drug prices, FDA commissioner nominee Robert Califf told a Senate committee during his confirmation hearing (Also see "FDA Can Help On Drug Prices – Except When It Can't, Califf Says" - Pink Sheet, 17 Nov, 2015.).

GDUFA Helps FDA Focus On Generic Quality

FDA has made a concerted effort to improve generic manufacturing quality since the generic drug user fee program launched in 2012.

Part of the agency’s agreement with industry to create the program included moving to parity between the number of foreign and domestic facility inspections (Also see "Risk-Based Inspections Might Actually Be Hurting Compliant Firms" - Pink Sheet, 6 Jul, 2015.).

FDA also is in the midst of creating a program to collect data on quality measures from manufacturers, in part to inform its inspection plans, although industry has many concerns (Also see "FDA Quality Metrics Proposal Sparks Objections, Disarray" - Pink Sheet, 25 Sep, 2015.).

The agency also launched its Office of Pharmaceutical Quality in January 2015, which is dedicated to overseeing GMP and related oversight within CDER (Also see "Woodcock’s Passion Project: CDER Chief Shifts Duties To Lead Quality Office" - Pink Sheet, 19 Jan, 2015.).

[Editor’s Note: This article first appeared in “The Pink Sheet” DAILY.]