In the debate over how best to stem the tide of rising health care costs, prescription drug costs play a defining role. Prescription drugs now represent the single fastest growing component of overall health care costs. Increasing consumer demand, direct advertising of pharmaceuticals to consumers, and a lack of competition in the pharmaceutical marketplace are creating an environment of double-digit annual increases in prescription drug costs.

One answer to address the skyrocketing cost of prescription drugs is to increase competition in the marketplace and consumer access to lower-cost generic drugs. By closing loopholes that prevent generics from coming to market, data shows consumers could experience cost savings from 30 percent to 75 percent.

Establish a Definitive, Efficient FDA Approval Process for Biogenerics

Right now, a clear pathway for the development and approval of generics for an entire class of pharmaceuticals called biopharmaceuticals, or drugs that are derived from living sources, does not exist. Biopharmaceuticals are used in the fight against cancer, multiple sclerosis, diabetes, and many other conditions and diseases, and include antibiotics, insulin, interferons, and classic vaccines including Polio and DPT.

Given the technology that is required to manufacture these products, it is understandable that the prices of biopharmaceuticals are exceedingly high compared to traditional pharmaceuticals. In fact, the average cost in 2003 for a one-day supply of a biopharmaceutical was $45.00, but only $1.66 for all other drugs. And now that billions of dollars worth of biopharmaceutical patents are expiring, it is especially important to establish a definitive, efficient FDA approval process for affordable biogenerics in order to ensure consumer access to these life-saving drugs. Opening up the biopharmaceutical market to generic manufacturers would also ensure an ample supply of medicines in the case of a national epidemic, as seen with the shortage of flu vaccines in recent years.

In some cases, brand name drug manufacturers are using legal loopholes to extend their patents and prevent or delay generic drugs from coming to the market.  The 110th Congress must pass legislation like the Lower PRICED Drugs Act (S. 2300) – a bipartisan bill sponsored by Senators Stabenow and Lott in the 109th Congress – to close these loopholes to: 

• Ensure proper use of the pediatric exclusivity provision
  Under current law, drug companies may be given extended marketing protections to encourage them to determine whether their drugs may be used in children. But some drug companies are using these protections to keep cheaper generic alternatives from becoming available to consumers, even when the drug receiving this protection is not intended for children or was never studied in children. For example, Fosamax, a widely-used drug to treat osteoporosis with $2 billion in annual sales, received a pediatric extension.
  

• Remove an arbitrary roadblock to generic versions of certain antibiotics
  Although generic drug labeling is generally required to be the same as that approved for the brand name drug, generic applicants are allowed to “carve out” aspects of the brand label covered by patents that go beyond the original use of the drug. The “carve out” allows market entry of generic products used to treat specific diseases or conditions, or to be used in certain ways, without infringing patents for uses for which the generic is not seeking to compete.
  
  However, the ability to carve out labeling is limited to patents listed in the “Orange Book” (the FDA’s official compilation of drug patents).  Because antibiotics licensed prior to November 12, 1997 are not listed in the Orange Book, and thus no carve-outs are allowed for these products, American consumers are effectively denied generic versions of this essential category of drugs.
  
  
• Prevent delays in the generic drug approval process
  Before a generic drug can come to market, the generic applicant must get FDA approval and state whether it will challenge any of the relevant patents held by the brand manufacturer.  This challenge often spurs a lawsuit by the brand that triggers a 30-month delay before the FDA can approve the generic drug.
  
  Although the law states that the courts may shorten the 30-month “stay” period, the stay is very rarely shortened, even in cases of egregious brand company delay tactics.  The delay tactics can, and do, prevent generic availability indefinitely.
  
  
• Prevent abuse of the citizen petition process
  The citizen petition (CP) process is intended to allow citizens to raise for FDA’s consideration legitimate issues relating to drug products. But the FDA publicly has acknowledged that brand-company abuse of the CP process is a serious problem. 
  
  Brand companies often file citizen petitions about the time that patent protection for their products is set to expire or as litigation involving their patents is coming to a close.  Waiting until this point allows brand companies to maintain their drug monopolies because FDA has taken over 9 months, on average, to address issues in brand companies’ CPs. As a result, approval of first-time generics can be delayed for months. 
  

Speed the Review and Approval of Generic Drug Applications

The 110th Congress must increase funding for the Office of Generic Drugs (OGD).  Since the patents on numerous brand name drugs are set to expire in the next few years, reducing the backlog of generic drug applications at OGD is more critical than ever.  This backlog has grown steadily in recent years, while funding for the review and approval of generic applications has remained flat.  The FDA expects to receive record numbers of new applications for generic drugs in the coming years.  Substantially increasing resources for the OGD is critical to reduce the current backlog and increase competition in the pharmaceutical market.

What's At Stake in the Drug Debate?

Consumers' health is at stake. Congress must provide a definitive pathway for biogenerics, close the loopholes that unfairly extend brand drug patents and increase funding for the Office of Generic Drugs (OGD) to speed the review of generic drug applications. 

Ask your lawmakers to support competition in the pharmaceutical marketplace and protect consumer access to generics.