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Senators have drawn up about 20 amendments for today's Health, Education, Labor and Pensions Committee markup of a bill allowing FDA to approve generic versions of biologic drugs.
The bill will create an approval path for low-cost versions of drugs made from living organisms, including insulin and Epogen, the anemia treatment for kidney failure patients on which Medicare spends almost $2 billion annually.
Industry sources don't believe any amendments will pass that drastically change the deal HELP Committee leaders and Sens. Orrin Hatch, R-Utah, and Hillary Rodham Clinton and Charles Schumer, both New York Democrats, reached late last week.
Congress enacted a generic approval pathway for traditional, less-complex chemical drugs in 1984.
A sticking point for the generic biologics bill was the number of years brand-name biologic drugmakers would be able to sell their products free from generic competition. The senators settled on 12 years, at least seven years longer than the exclusivity period offered traditional brand-name drugs. Sen. Sherrod Brown, D-Ohio, has an amendment that would cut the exclusivity window to seven years, though sources do not expect it to pass.
Sen. Lamar Alexander, R-Tenn., has an amendment that would tack on an additional six-month exclusivity period if biologic drugmakers conduct pediatric research.
Traditional drugs are offered the same incentive, but some say whether biologics are explicitly included is unclear.
Sen. Richard Burr, D-N.C., also would like to give brand biologic companies an extra six months free from generic competition if they gain approval for drugs to treat diseases other than those already approved.
Sen. Tom Coburn, R-Okla., has eight amendments. All but one seek to tighten provisions to resolve patent disputes, though they are not expected to be brought up for a vote.
Sen. Judd Gregg, R-N.H., also has an amendment to require FDA to issue guidelines for industry to achieve interchangeability -- meaning the generic can be substituted for the brand -- before FDA approves an interchangeable drug.
Brand industry supporters question whether generic biologics are too complex to safely substitute one for the other.
Committee Democratic staff said they did not require guidelines immediately because they wanted FDA to gain experience first.
Once the bill passes the full Senate, committee Democratic staff said they expect either the House will include generic biologic language in its omnibus FDA bill or accept it as part of the bill during conference.
The Senate passed its omnibus FDA bill last month, and did not include generic biologic language because it was not nearly complete.
A majority staffer with the House Energy and Commerce Committee said generic biologic language is not expected to be added to its FDA bill, but the aide added the chances would depend on how the Rules Committee delineates debate. The majority staffer said lawmakers hope to determine rules for debate this week.
The bill will create an approval path for low-cost versions of drugs made from living organisms, including insulin and Epogen, the anemia treatment for kidney failure patients on which Medicare spends almost $2 billion annually.
Industry sources don't believe any amendments will pass that drastically change the deal HELP Committee leaders and Sens. Orrin Hatch, R-Utah, and Hillary Rodham Clinton and Charles Schumer, both New York Democrats, reached late last week.
Congress enacted a generic approval pathway for traditional, less-complex chemical drugs in 1984.
A sticking point for the generic biologics bill was the number of years brand-name biologic drugmakers would be able to sell their products free from generic competition. The senators settled on 12 years, at least seven years longer than the exclusivity period offered traditional brand-name drugs. Sen. Sherrod Brown, D-Ohio, has an amendment that would cut the exclusivity window to seven years, though sources do not expect it to pass.
Sen. Lamar Alexander, R-Tenn., has an amendment that would tack on an additional six-month exclusivity period if biologic drugmakers conduct pediatric research.
Traditional drugs are offered the same incentive, but some say whether biologics are explicitly included is unclear.
Sen. Richard Burr, D-N.C., also would like to give brand biologic companies an extra six months free from generic competition if they gain approval for drugs to treat diseases other than those already approved.
Sen. Tom Coburn, R-Okla., has eight amendments. All but one seek to tighten provisions to resolve patent disputes, though they are not expected to be brought up for a vote.
Sen. Judd Gregg, R-N.H., also has an amendment to require FDA to issue guidelines for industry to achieve interchangeability -- meaning the generic can be substituted for the brand -- before FDA approves an interchangeable drug.
Brand industry supporters question whether generic biologics are too complex to safely substitute one for the other.
Committee Democratic staff said they did not require guidelines immediately because they wanted FDA to gain experience first.
Once the bill passes the full Senate, committee Democratic staff said they expect either the House will include generic biologic language in its omnibus FDA bill or accept it as part of the bill during conference.
The Senate passed its omnibus FDA bill last month, and did not include generic biologic language because it was not nearly complete.
A majority staffer with the House Energy and Commerce Committee said generic biologic language is not expected to be added to its FDA bill, but the aide added the chances would depend on how the Rules Committee delineates debate. The majority staffer said lawmakers hope to determine rules for debate this week.
