Sitting atop the approval process for prescription
medications, Dr. Scott Gottlieb is a little different from some of his more
bureaucratic predecessors: He's listening.
Last month, the commissioner of the Food and Drug
Administration hosted a public meeting to solicit input from patients, care
providers, and drug makers on how to improve the FDA's drug approval process
and, just as importantly, expedite the introduction of generic drugs.
Far too often in Washington, regulators approach their
mission by dictating terms to those in their purview. Gottlieb is different:
His starting point is how the FDA can most efficiently get safe and effective
treatments to the patients who need them. Improving the FDA's processes can
drive healthcare costs down dramatically and save millions of lives.
Take generics: Between 2005 and 2014, generics generated
about $1.7 trillion in healthcare savings in America.
They also pressure rival products to lower their prices. One
FDA study found that when a brand-name drug has eight generic competitors,
patients buying the generic versions pay on average just 20 percent of the cost
of the brand name. When a drug has only four generic versions, patients pay
twice as much -- 40 percent of the brand-name price.
And with only one generic competitor, generic buyers will
see a minimal discount, paying on average 94 percent of the price of the
brand-name. So in Gottlieb's view, the more the better.
But speeding up generic approvals will be a challenge. The
existing FDA channels are notoriously slow, gummed up with antiquated
procedures. It's been 30 years since the federal law governing generics has
been significantly updated. The rules are especially unclear for complex
generic drugs using delivery mechanisms that were invented only in the past few
This uncertainty lengthens the time it takes for a generic
drug to win approval. The FDA is now staring down a backlog of 2,600 pending
applications. Today, getting a new generic approved costs about $5 million and
takes four years.
With delayed approval of generics, brand name drugs face
less competition. For all too many drugs whose patents have expired, few
companies if any have stepped up to create rival generic products. For about 10
percent of off-patent drugs, the FDA has received not a single generic
Without competition from other drug makers, manufacturers
can charge monopoly-level prices even for decades-old medications. That's
exactly what happened with the price hike that brought "Pharma Bro"
Martin Shkreli to national notoriety. Shkreli's firm acquired the rights to
produce the infection medication Daraprim -- then immediately jacked up the
price from $13 to $750. That hike only was possible because Daraprim had no
real generic competition.
Commissioner Gottlieb has made ending the needless delays
his top priority. His team has already started clearing out the application
backlog and has announced plans to provide faster consideration for
applications for drugs for which there are fewer than three firms currently
The FDA will also publish a list of off-patent drugs for
which no company has applied to produce a generic version. The agency hopes
that collecting that information and publicizing it will attract competitors
into the market and also reduce the potential for life-threatening drug
Gottlieb is tackling a tough and urgent public health issue
head on. And Congress is helping -- specifically through reauthorizing the
Prescription Drug User Fee Act (PDUFA), a breakthrough 1992 piece of federal
legislation that requires drug companies to pay fees to cover the cost of the
review and approval of their products.
Back in the early 90s, the FDA was drowning in drug
applications. It didn't have enough money or staff to review and approve
medications in the pipeline. So Congress passed PDUFA to shore up the agency's
financing and expedite reviews. The bill worked. The average drug approval time
fell from two and half years to just under 11 months. PDUFA has since helped
usher 1,500 new drugs to market.
Re-authorizing PDUFA will give Gottlieb the resources he
needs to make these reforms a reality. A life- and cost-saving revolution is
now underway at the FDA.
Peter J. Pitts, a former FDA associate commissioner, is
president of the Center for Medicine in the Public Interest.