Three issues that will define 2011

Years 2009 and 2010 were up and down for the generic drug industry and its main trade group, the Generic Pharmaceutical Association. On one hand, there were the departures of president and CEO Kathleen Jaeger and member company Teva Pharmaceutical Industries. On the other, a regulatory approval pathway for follow-on biologics was created — though it granted longer market exclusivity periods to biotech drugs than the GPhA desired — and there were increases in the use of generics, which accounted for 77% of dispensed prescriptions in the first half of 2010, according to IMS Health. 

But 2009 and 2010 are behind the industry, literally and figuratively. In interviews with Drug Store News, GPhA VP regulatory science Gordon Johnston and IMS Health VP industry relations Doug Long spoke about three issues that will be important for the industry in 2011 — probably in a good way.

1. Drug safety
: Drug approval in the United States is no easy task because of the strength of the Food and Drug Administration’s regulatory system. But the system still has weak points — particularly the inspection of foreign manufacturing plants. According to a September 2010 Government Accountability Office report, while the FDA inspected more than 1,000 domestic manufacturing plants in fiscal 2009, it inspected 424 in other countries, around 11% of the total.

That could change soon. “Whether supply chain safety comes in the form of legislation or FDA regulations, we ... expect to see something coming down the pike in 2011,” Johnston said. Long, however, told Drug Store News he didn’t expect to see “anything major” this year.

2. Generic user fees
: A perennial problem facing the generic drug industry is the backlog of applications at the FDA’s Office of Generic Drugs — and it keeps getting bigger. According to the GPhA, the number of applications submitted to the office increased from 361 in 2002, to 830 in 2008, creating a backlog of almost 2,000 applications in 2010, according to a presentation by office director Gary Buehler at the GPhA’s 2010 annual meeting. While federal regulations allow six months’ review time for an application, in practice it often takes 21 months.

Johnston said he expected a user fee program to be implemented by 2013. “I expect that a user fee program will be designed and recommended this year, with [the] industry and FDA working together,” he said.

Long agreed. “There is a very good possibility that user fees will be passed by Congress in 2011,” he said.

3. Patent settlements
: When a generics company wants to market its version of a drug ahead of the branded version’s patent expiration, it will file an application with a paragraph-IV certification, asserting the patent is invalid, unenforceable or won’t be infringed, thus usually prompting a lawsuit from the branded drug’s manufacturer. In most cases, the two companies will settle, allowing the generics company to market its drug ahead of patent expiration in exchange for not immediately launching. Delaying launch after a patent has expired would be illegal.

The Federal Trade Commission has assailed the settlements as “pay-for-delay” deals and has sought to ban them, asserting they cost taxpayers $3.5 billion per year. The FTC may find its efforts frustrated with the Republican majority in the House, but it could use other means as well. Johnston said the outcome in Congress was difficult to determine. “Regardless of what happens on the legislative front, this issue may go to the Supreme Court to decide,” Long said.

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