RegBits: The Biggest Regulatory Stories of the Week (That we Forgot to Cover)

Posted 21 November 2014 | By Alexander Gaffney, RAC 

RegBits: The Biggest Regulatory Stories of the Week (That we Forgot to Cover)

As much as we manage to cover here at Regulatory Focus, there's often just as much that we don't manage to write about despite our best intentions. RegBits is our occasional look at some of the biggest and most interesting stories that managed to escape our keyboards, but not our attention.

Average Trial Size Needed to Obtain FDA Approval

Knowledge Economy International (KEI), an intellectual property-focused think tank in favor of increased availability of drug products, released an interesting data set this week looking at the size of the clinical trials used to obtain FDA approval for a new drug product.

KEI analyzed all drug products approved by FDA in 2010, which included six new biologic drugs and 15 new molecular entities.

"For the 2010 approvals, we report on data on the size of trials that were cited in the FDA medical review associated with the approval of the drug, as well as the information about trials published on the drug label," KEI wrote. "The data from the FDA Medical Reviews are more inclusive and include Phase I, II and III trials, while the data from Section 14 of the FDA label for the drug typically reports only the key trials used to evaluate safety and efficacy."

KEI found it takes as average of 5,224 patients to obtain drug approval from FDA, but a closer look at its data reveals this average to be highly misleading. The median number of patients, it found, was 2,655 patients per product, indicating that a few drugs skewed the average significantly higher.

Most drugs, KEI found, could be approved with trials on fewer than 2,000 patients. Orphan drugs could be approved using even fewer patients—976 on average, and 406 on median.

(KEI Study)

Device Recalls Increase 8% in Q3 2014

A new report out from one of the world's largest product recall firms, SteriCycle, finds that device recalls increased 8% in the third quarter of 2014. There were 297 recalls during that quarter, the report found.

"Fifty-seven percent of Q3’s medical device recalls affected the U.S. and at least one other country, and the majority of medical device recalls since Q3 2010 have been Class II events," SteriCycle wrote. Labeling, packaging and software errors were main contributors to the recalls.


FDA Revises Guidance on Handling Petitions to Delay Generic Drug Approvals

Earlier this week, Focus had a lengthy article explaining FDA's 505(q) petition process, which is used by companies to seek a delay in the approval of a generic competitor. As we noted at the time, FDA data indicate it rejects these applications in nearly all cases, with just a handful (8) approved over the years, and 31 approved in part. FDA rejected 83, it said.

Now the agency has quietly unveiled a revised version of its guidance document on 505(q) petitions, explaining how it handles them, the process by which it rejects them, and its various intricacies. Irritatingly, because the agency classifies the guidance as a Level II guidance—procedural—there's no explanation of how the guidance is different from previous iterations.

(Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act)

Tougher Patents, More Innovation

The Biotechnology Industry Organization (BIO) published an analysis of a recent National Bureau of Economic Research (NBER) working paper showing that tougher patent regimes are associated with high levels of innovation, and specifically with more drugs launched.

"Based on drug launch data comprising of over 600 drugs in almost 80 countries from 1983-2002, the NBER study found that price regulation strongly delays launch, while longer and more extensive patent protection accelerates it," BIO explained.

Price controls were also negatively correlated with drug launches, the report found.

(BIO Analysis) (NBER Report)

White House Throws Support behind FDA Voucher Reform Bill

The White House rarely even mentions FDA, except perhaps for its food-related operations—a favorite topic of nutrition-minded first lady Michelle Obama—and when it threw hurdles in the way of approving an over-the-counter version of Plan B (levonorgestrel) prior to the 2012 election.

But this week the White House said it supported the Adding Ebola to the FDA Priority Review Voucher Program Act, a new bill reforming a rarely used and little-known voucher program implemented by FDA after the 2007 passage of the Food and Drug Administration Amendments Act (FDAAA).

Writing in a blog post, the White House's Ebola Response Coordinator Ron Klain lauded the bill as an "encouraging" and "hopeful" step indicating that the issue of Ebola is finding bipartisan support. "We welcome bipartisan legislative efforts against this threat," Klain said.

(White House)

How Can FDA Increase Generic Competition?

A new white paper published by Matrix Global Advisors proposes that FDA make a number of changes it says will increase generic competition and bring down the price of generic drugs—an issue that has recently received congressional attention.

The report makes four notable recommendations:

  • FDA should expedite generic drug approvals for products which, if approved, would greatly increase competition in the marketplace.
  • FDA should try decrease the median approval time for abbreviated new drug applications (used to approve generic drugs), which now stands at 36 months.
  • FDA should finalize the creation of the biosimilar pathway through additional guidance, especially on the naming of biosimilar products.
  • Congress should give FDA additional funding for generic drug regulation.

"How the FDA uses its authority to promote competition and innovation can impact both the availability of new cures but also the cost of prescription drugs," study author Alex Brill noted.

(White Paper)

OIG: Drug and Device Safety a Top Challenge

A report issued this week by the US Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG) explains that ensuring the safety of drugs and medical devices remains one of DHHS' top challenges.

Key areas of concern, the report notes, are the compounding of drug products, the safety of imported drug products, the marketing of pharmaceutical and device products and the implementation of the Drug Quality and Security Act of 2013.

(OIG Report)

Should FDA Change its Regulation of Hearing Aids?

In November 2013, FDA released a draft guidance regarding the regulatory differences between FDA-regulated hearing aids and another type of device referred to as "personal sound amplification products" (PSAPs). The former is a prescription medical device used to help people who have lost their ability to hear properly, while the latter is meant to just amplify sounds (useful if you want to watch TV quietly in the same room as your sleeping spouse, for example).

As an op-ed in the conservative-leaning Daily Caller argues, FDA's regulatory distinction is one with big impacts on the wallets of consumers. Hearing aids cost between $1,000 and $6,000, the op-ed notes, citing a survey from the Consumer Electronics Association (CEA).

PSAP products, meanwhile, cost a tenth of that.

"The FDA’s guidance prevents PSAP companies from effectively marketing their devices by restricting PSAP use to non-hearing impaired consumers with a very limited set of recreational needs – bird watching or hunting, for example. As a result, even consumers with only very minimal or mild hearing loss are not able to benefit from these more affordable options," claims Gary Shapiro, president of CEA.

"It’s time the government eases federal marketing restrictions on PSAPs and allows consumers to access affordable and readily available hearing solutions," he concludes.

(Daily Caller)

FDA Veterinary Grant

FDA announced this week it is accepting applications for a grant program intended to develop drugs for orphan conditions in animals. FDA's animal orphan drug program, known as the Minor Use/Minor Species (MUMS), was established in 2004.

The same program authorizes funding meant to help conduct early-stage drug research. Depending on the research, grants can max out at $375,000 per year.

(FDA Notice)

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