Drug Industry

Congress isn’t making much headway in finding a solution to the problem of soaring prescription drug prices, but lawmakers from both parties are tinkering on the edges with legislation that aims to increase competition among drugmakers. A comprehensive piece of drug-pricing legislation is a high priority for Senate Finance Committee Chairman Chuck Grassley, (R-Iowa) and Sen. Ron Wyden (D-Ore.). And it be introduce by mid June, according to congressional staff.
But while that is hashed out, a slate of options to reform drug patents; hence is working its way through the Senate Judiciary Committee; which had a hearing Tuesday featuring academics; so patient advocates and a representative from the pharmaceutical industry. Their mission to increase competition without decreasing innovation in the industry.

Thorny issues around drug pricing

They think they’re dangerously close to building a bipartisanship consensus around change,” Sen. Dick Durbin (D-Ill.), said during the hearing. The four propose bills share a common goal: avoiding some of the thorny issues around drug pricing, like whether the government will set drug prices or negotiate with manufacturers on what federal programs will pay.

Instead, the patent reform proposals get at the ways brand drug manufacturers use patents; also the legal monopolies that are grant with patents, to keep lower price generic competitors from reaching patients. A package of patent reforms are important because they fix systemic problems that allow prices to go up and keep them high, testify David Mitchell, the president of Patients for Affordable Drugs, a Washington, D.C. base advocacy group focus on lowering prescription drug prices.
Sen. John Cornyn (R-Texas) offer specific examples of drugs that have benefit from  system issues; so including Humira, an expensive drug for arthritis and psoriasis that is protect by 136 patents. That’s called a “patent thicket,” because it prevents a generic alternative from entering the market for more years in this case; hence until 2023 for a drug first approve for use in the United States in 2002.

Approval of new generic medicines

Amy Klobuchar (D-Minn.) and Grassley. The bill is suppose to put a stop to “sham” citizen petitions to the FDA. Critics say these petitions are often introduce by drug makers under the guise of patient advocacy to slow FDA approval of new generic medicines. “Nearly every one of these citizen petitions is bring by a brand company. None are file by individuals. I love the legislation. they would go even stronger, Carrier said.
Klobuchar and Grassley team up again on another measure; so the Preserve Access to Affordable Generics and Biosimilars Act, which they  say would end “anti competitive behavior” specifically; so the deals struck between brand companies and generic companies to keep a generic, or a biosimilar, off the market. Klobuchar,  a Democratic presidential candidate; hence has frequently discuss her opposition to this practice on the campaign trail.
James Stansel the executive vice president and general counsel of the Pharmaceutical Research and Manufacturers of America, a drug industry trade group, and the lone voice of the pharmaceutical industry on the panel caution against moving too aggressively on this point. “They want to make sure they don’t do something that’s anti-competitive in the hopes it would be pro-competitive,” They said.