The House is scrambling to speed up drug approvals as treatment costs balloon.
Skyrocketing prices for new treatments are the top healthcare priority for 76 percent of consumers, according to a recent poll from Kaiser Family Foundation. The House Energy & Commerce Committee’s released a draft earlier this week that doesn’t address prices directly but may help in a roundabout way, experts said.
The proposal, introduced earlier this week, seeks to modernize clinical trials, speed up regulatory approval of drugs to treat serious diseases, and increase research funding.
The policies will help “lower the cost and reduce the time it takes to bring treatments to patients,” a source told the Washington Examiner.
Drug development cost is part of the reason prices are so high. A 2014 study from Tufts University found it takes $2.6 billion and a decade to develop a new prescription medicine.
The bill would allow more products to apply for accelerated approval, which means manufacturers can submit less clinical data to get approved. The method is heavily used for HIV and cancer drugs, but the new law would accelerate the process for other types of therapies as well.
Normally a maker of a cancer drug would have to submit clinical data on how many patients were cured or died while on the drug, which can take many years. Drugs seeking accelerated approval only need to show they can shrink cancerous tumors, Alexander Varond, an attorney with the firm Hyman, Phelps & McNamara, told the Washington Examiner.
The draft bill also aims to increase the use of biomarkers, which are tests to determine if a treatment is right for a patient. It calls on the Food and Drug Administration to issue regulatory guidance on how drug makers can develop new biomarkers.
Biomarks can help drugmakers reduce the size of clinical trials through determining whether a patient is right for the treatment, said Varond.
However, less time to market is no guarantee companies will lower prices.
A recent report found that prices for specialty drugs that treat chronic conditions such as hepatitis C and cancer often outpace the growth of inflation and are rising for no reason. The pro-healthcare reform group National Coalition on Health Care wrote the report.
Such specialty drugs are the focal point of pricing critics.
Case in point, Gilead’s hepatitis C drugs Sovaldi and Harvoni, which each cost about $1,000 a pill. The drugs together generated about $4.5 billion for Gilead in just the first quarter of this year, according to the company’s latest financial report.
A recent study also found that first generation multiple sclerosis drugs have increased from up to $11,000 a year to about $60,000 a year.
Generic drug prices are also rising. A 2014 study found that half of all generic drugs became more expensive that year compared to the year before.
However, generic drug prices are mostly rising due to taking advantage of supply shortages, according to the study conducted by the Drug Channels Institute, a consulting and training company for the pharmaceutical industry.
To be sure, lawmakers did cut an earlier provision that could have led to higher drug prices, Varond said.
A draft released in January called for brand-name products to get more market exclusivity if they addressed an unmet need or improved on an existing drug. Market exclusivity means that no cheaper copycat versions of the drug can be approved during that period — instead of five years of market exclusivity, such drugs would get 15 years.
